{
  "@context": {
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      "@id": "au:claims",
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
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    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0939-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8\" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5\"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5\" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5\" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2\" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7\"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERILE RUSSIAN TISSUE FCP 6\" STER25,Model Number 96-2295A;   15) ECONO STERILE TISSUE FCP 1X2 8\" STRL CS/25,Model Number 96-2351;   16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;   17) ECONO STERILE TUBE OCCL FCP SM STR 7\"STER 50,Model Number 96-2406;   18) ECONO STERILE TUBE OCC FCP SM STR 7\" STER 25,Model Number 96-2408;   19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;   20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;   21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;   22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;   23) ECONO STERILE SEMKEN DRESS FCP SERR 5\"STER25,Model Number 96-2450M;   24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;   25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;   26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;   27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;   28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;   29) ECONO STERILE IRIS FCP 1/2CVD 1x2  STER CS25,Model Number 96-2515A;   30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;   31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;   32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;   33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;   34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;   35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;   36) ECONO STERILE IRIS FCP STR 1X2 4\" STER CS/25,Model Number 96-2535A;   37) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536;   38) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536M;   39) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537;   40) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537A;   41) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537M;   42) ECONO STERILE HALSTED FCP CVD 5\" STER CS/50,Model Number 96-2538;   43) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539;   44) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539A;   45) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539M;   46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;   47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;   48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;   49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;   50) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 25,Model Number 96-2548;   51) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 50,Model Number 96-2549;   52) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/50,Model Number 96-2550;   53) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551;   54) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551A;",
  "description": "FDA recall Z-0939-2025 — Sklar Instruments is recalling ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8\" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5\"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5\" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5\" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2\" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7\"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERILE RUSSIAN TISSUE FCP 6\" STER25,Model Number 96-2295A;   15) ECONO STERILE TISSUE FCP 1X2 8\" STRL CS/25,Model Number 96-2351;   16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;   17) ECONO STERILE TUBE OCCL FCP SM STR 7\"STER 50,Model Number 96-2406;   18) ECONO STERILE TUBE OCC FCP SM STR 7\" STER 25,Model Number 96-2408;   19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;   20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;   21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;   22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;   23) ECONO STERILE SEMKEN DRESS FCP SERR 5\"STER25,Model Number 96-2450M;   24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;   25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;   26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;   27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;   28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;   29) ECONO STERILE IRIS FCP 1/2CVD 1x2  STER CS25,Model Number 96-2515A;   30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;   31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;   32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;   33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;   34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;   35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;   36) ECONO STERILE IRIS FCP STR 1X2 4\" STER CS/25,Model Number 96-2535A;   37) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536;   38) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536M;   39) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537;   40) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537A;   41) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537M;   42) ECONO STERILE HALSTED FCP CVD 5\" STER CS/50,Model Number 96-2538;   43) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539;   44) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539A;   45) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539M;   46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;   47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;   48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;   49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;   50) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 25,Model Number 96-2548;   51) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 50,Model Number 96-2549;   52) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/50,Model Number 96-2550;   53) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551;   54) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551A; (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0939-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8\" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5\"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5\" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5\" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2\" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7\"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERILE RUSSIAN TISSUE FCP 6\" STER25,Model Number 96-2295A;   15) ECONO STERILE TISSUE FCP 1X2 8\" STRL CS/25,Model Number 96-2351;   16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;   17) ECONO STERILE TUBE OCCL FCP SM STR 7\"STER 50,Model Number 96-2406;   18) ECONO STERILE TUBE OCC FCP SM STR 7\" STER 25,Model Number 96-2408;   19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;   20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;   21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;   22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;   23) ECONO STERILE SEMKEN DRESS FCP SERR 5\"STER25,Model Number 96-2450M;   24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;   25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;   26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;   27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;   28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;   29) ECONO STERILE IRIS FCP 1/2CVD 1x2  STER CS25,Model Number 96-2515A;   30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;   31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;   32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;   33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;   34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;   35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;   36) ECONO STERILE IRIS FCP STR 1X2 4\" STER CS/25,Model Number 96-2535A;   37) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536;   38) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536M;   39) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537;   40) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537A;   41) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537M;   42) ECONO STERILE HALSTED FCP CVD 5\" STER CS/50,Model Number 96-2538;   43) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539;   44) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539A;   45) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539M;   46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;   47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;   48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;   49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;   50) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 25,Model Number 96-2548;   51) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 50,Model Number 96-2549;   52) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/50,Model Number 96-2550;   53) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551;   54) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551A;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Sklar Instruments"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0939-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0939-2025: Sklar Instruments is recalling ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8\" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5\"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5\" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5\" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2\" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7\"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERILE RUSSIAN TISSUE FCP 6\" STER25,Model Number 96-2295A;   15) ECONO STERILE TISSUE FCP 1X2 8\" STRL CS/25,Model Number 96-2351;   16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;   17) ECONO STERILE TUBE OCCL FCP SM STR 7\"STER 50,Model Number 96-2406;   18) ECONO STERILE TUBE OCC FCP SM STR 7\" STER 25,Model Number 96-2408;   19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;   20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;   21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;   22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;   23) ECONO STERILE SEMKEN DRESS FCP SERR 5\"STER25,Model Number 96-2450M;   24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;   25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;   26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;   27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;   28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;   29) ECONO STERILE IRIS FCP 1/2CVD 1x2  STER CS25,Model Number 96-2515A;   30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;   31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;   32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;   33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;   34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;   35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;   36) ECONO STERILE IRIS FCP STR 1X2 4\" STER CS/25,Model Number 96-2535A;   37) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536;   38) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536M;   39) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537;   40) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537A;   41) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537M;   42) ECONO STERILE HALSTED FCP CVD 5\" STER CS/50,Model Number 96-2538;   43) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539;   44) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539A;   45) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539M;   46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;   47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;   48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;   49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;   50) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 25,Model Number 96-2548;   51) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 50,Model Number 96-2549;   52) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/50,Model Number 96-2550;   53) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551;   54) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551A;",
      "text": "The FDA logged enforcement record Z-0939-2025: Sklar Instruments is voluntarily recalling ECONO STERILE medical procedure kits labeled as:    1) ECONO STERILE ROCH-PEAN FCP 8\" CVD CS/25,Model Number 94-0286;   2) ECONO STERILE DRESSING FCP 5.5\"  CS/25LG,Model Number 94-0290;   3) ECONO STERILE TISSUE FCP 1X2 5.5\" STER CS25,Model Number 94-0291;   4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;   5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;   6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;   7) ECONO STERILE STRL ALLIGATOR FCPS 3.5\" 25/CS,Model Number 94-5034;   8) ECONO STERILE SERR DRESSING FCP 5 1/2\" CS/50,Model Number 94-6146;   9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;   10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;   11) ECONO STERILE BALLENGR SPNG FCP SERR7\"CS/25,Model Number 96-2289;   12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;   13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;   14) ECONO STERILE RUSSIAN TISSUE FCP 6\" STER25,Model Number 96-2295A;   15) ECONO STERILE TISSUE FCP 1X2 8\" STRL CS/25,Model Number 96-2351;   16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;   17) ECONO STERILE TUBE OCCL FCP SM STR 7\"STER 50,Model Number 96-2406;   18) ECONO STERILE TUBE OCC FCP SM STR 7\" STER 25,Model Number 96-2408;   19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;   20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;   21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;   22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;   23) ECONO STERILE SEMKEN DRESS FCP SERR 5\"STER25,Model Number 96-2450M;   24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;   25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;   26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;   27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;   28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;   29) ECONO STERILE IRIS FCP 1/2CVD 1x2  STER CS25,Model Number 96-2515A;   30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;   31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;   32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;   33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;   34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;   35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;   36) ECONO STERILE IRIS FCP STR 1X2 4\" STER CS/25,Model Number 96-2535A;   37) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536;   38) ECONO STERILE HALSTED FCP STR 5\" STER CS/50,Model Number 96-2536M;   39) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537;   40) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537A;   41) ECONO STERILE HALSTED FCP STR 5\" STER CS/25,Model Number 96-2537M;   42) ECONO STERILE HALSTED FCP CVD 5\" STER CS/50,Model Number 96-2538;   43) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539;   44) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539A;   45) ECONO STERILE HALSTED FCP CVD 5\" STER CS/25,Model Number 96-2539M;   46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;   47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;   48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;   49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;   50) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 25,Model Number 96-2548;   51) ECONO STERILE ROCH-PEAN FCP CVD 8.5\" STER 50,Model Number 96-2549;   52) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/50,Model Number 96-2550;   53) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551;   54) ECONO STERILE CRILE FCP STR 5.5\" STERL CS/25,Model Number 96-2551A; — reason: Reports of various packaging issues that may result in a breach of the sterile barrier.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-03. Affected lots/codes: 1) 94-0286, UDI/DI 50649111094406, Lot codes:  FSF21;  2) 94-0290, UDI/DI 50649111095045, Lot codes:  SK-115;  3) 94-0291, UDI/DI 50649111095144, Lot codes:  824940291, 924940291;  4) 941-0691, UDI/DI 50649111307902, Lot codes:  MST8, MST9;  5) 941-1414, UDI/DI 50649111464872, Lot codes:  SK-122;  6) 94-1924, UDI/DI 50649111345775, Lot codes:  FSF16, FSF22;  7) 94-5034, UDI/DI 50649111040687, Lot codes:  SK-112, SK-135;  8) 94-6146, UDI/DI 50649111215535, Lot codes:  SK-135;  9) 94-6616, UDI/DI 50649111287457, Lot codes:  SK-132;  10) 96-2215A, UDI/DI 50649111487567, Lot codes:  HSI;  11) 96-2289, UDI/DI 50649111439986, Lot codes:  SK-116;  12) 96-2293, UDI/DI 50649111440012, Lot codes:  SK-115, SK-132;  13) 96-2293A, UDI/DI 50649111487598, Lot codes:  HSI;  14) 96-2295A, UDI/DI 50649111493254, Lot codes:  HST21;  15) 96-2351, UDI/DI 50649111440081, Lot codes:  FST21;  16) 96-2386, UDI/DI 50649111440241, Lot codes:  FSF18;  17) 96-2406, UDI/DI 50649111035195, Lot codes:  FSF18, FSF24, FSF25;  18) 96-2408, UDI/DI 50649111035355, Lot codes:  FSF5, FSF12, FSF18, FSF26;  19) 96-2410, UDI/DI 50649111035669, Lot codes:  FST9;  20) 96-2412, UDI/DI 50649111035867, Lot codes:  FST6, FST9, FST10, FST11, FST12, FST20;  21) 96-2412A, UDI/DI 50649111487550, Lot codes:  SK-112;  22) 96-2412M, UDI/DI 50649111027015, Lot codes:  0724962412M;  23) 96-2450M, UDI/DI 50649111464483, Lot codes:  0624962450M;  24) 96-2461, UDI/DI 50649111440432, Lot codes:  SK-132;  25) 96-2462, UDI/DI 50649111464490, Lot codes:  SK-132;  26) 96-2470A, UDI/DI 50649111487970, Lot codes:  SK-112;  27) 96-2472A, UDI/DI 50649111487987, Lot codes:  SK-112;  28) 96-2515, UDI/DI 50649111050235, Lot codes:  SK-115;  29) 96-2515A, UDI/DI 50649111487857, Lot codes:  SK-112;  30) 96-2532, UDI/DI 50649111053212, Lot codes:  FSF8, FSF14;  31) 96-2533, UDI/DI 50649111053397, Lot codes:  FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23;  32) 96-2533A, UDI/DI 50649111487888, Lot codes:  HSI;  33) 96-2533M, UDI/DI 50649111215313, Lot codes:  SK-116;  34) 96-2534, UDI/DI 50649111478817, Lot codes:  FSF15, FSF21, FSF22, FSF23;  35) 96-2534A, UDI/DI 50649111492653, Lot codes:  HSF8, HSF18;  36) 96-2535A, UDI/DI 50649111488304, Lot codes:  SK-112;  37) 96-2536, UDI/DI 50649111054172, Lot codes:  FSF10, FSF21;  38) 96-2536M, UDI/DI 50649111220034, Lot codes:  0724962536M;  39) 96-2537, UDI/DI 50649111054424, Lot codes:  FSF5, FSF10;  40) 96-2537A, UDI/DI 50649111219496, Lot codes:  SK-112;  41) 96-2537M, UDI/DI 50649111221758, Lot codes:  0724962537M;  42) 96-2538, UDI/DI 50649111054639, Lot codes:  FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23;  43) 96-2539, UDI/DI 50649111054783, Lot codes:  FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24;  44) 96-2539A, UDI/DI 50649111487901, Lot codes:  SK-112;  45) 96-2539M, UDI/DI 50649111225336, Lot codes:  0724962539M;  46) 96-2544, UDI/DI 50649111056008, Lot codes:  FSF8, FSF10;  47) 96-2545, UDI/DI 50649111056183, Lot codes:  FSF10, FSF21;  48) 96-2547, UDI/DI 50649111056497, Lot codes:  FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26;  49) 96-2547A, UDI/DI 50649111236417, Lot codes:  SK-112, SK-136;  50) 96-2548, UDI/DI 50649111056725, Lot codes:  FSF12;  51) 96-2549, UDI/DI 50649111056800, Lot codes:  FSF8, FSF17, FSF26;  52) 96-2550, UDI/DI 50649111057135, Lot codes:  FSF9, FSF19, FSF22, FSF24;  53) 96-2551, UDI/DI 50649111057234, Lot codes:  FSF9, FSF20, FSF24, FSF25;  54) 96-2551A, UDI/DI 50649111487819, Lot codes:  SK-112;  55) 96-2552, UDI/DI 50649111057579, Lot codes:  FSF13, FSF14, FSF16, FSF21, FSF24;  56) 96-2552M, UDI/DI 50649111400818, Lot codes:  SK-133;  57) 96-2553, UDI/DI 50649111057715, Lot codes:  FSF5;  58) 96-2554, UDI/DI 50649111057814, Lot codes:  SK-134;  59) 96-2555, UDI/DI 50649111057982, Lot codes:  FSF19, FSF20, FSF26;  60) 96-2556, UDI/DI 50649111058248, Lot codes:  SK-131;  61) 96-2557, UDI/DI 50649111058545, Lot codes:  FSF19, FSF26;  62) 96-2558, UDI/DI 50649111058644, Lot codes:  SK-131;  63) 96-2559, UDI/DI 50649111058903, Lot codes:  SK-115;  64) 96-2559A, UDI/DI 50649111487635, Lot codes:  SK-112;  65) 96-2560, UDI/DI 50649111059078, Lot codes:  FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26;  66) 96-2561, UDI/DI 50649111059290, Lot codes:  FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24;  67) 96-2561A, UDI/DI 50649111488007, Lot codes:  SK-112;  68) 96-2561M, UDI/DI 50649111259041, Lot codes:  0724962561M;  69) 96-2562, UDI/DI 50649111059511, Lot codes:  FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26;  70) 96-2563, UDI/DI 50649111059733, Lot codes:  FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24;  71) 96-2563A, UDI/DI 50649111487994, Lot codes:  SK-112;  72) 96-2563M, UDI/DI 50649111262218, Lot codes:  0724962563M;  73) 96-2566A, UDI/DI 50649111488175, Lot codes:  SK-112;  74) 96-2568, UDI/DI 50649111060531, Lot codes:  FST13, FST21;  75) 96-2568A, UDI/DI 50649111267558, Lot codes:  SK-115;  76) 96-2569, UDI/DI 50649111060715, Lot codes:  FST9, FST10, FST21;  77) 96-2569A, UDI/DI 50649111487840, Lot codes:  HSI;  78) 96-2570, UDI/DI 50649111060845, Lot codes:  SK-115;  79) 96-2570M, UDI/DI 50649111271821, Lot codes:  SK-116;  80) 96-2571, UDI/DI 50649111061033, Lot codes:  SK-115;  81) 96-2571A, UDI/DI 50649111487642, Lot codes:  HSI;  82) 96-2571M, UDI/DI 50649111273498, Lot codes:  SK-116;  83) 96-2572, UDI/DI 50649111061187, Lot codes:  SK-115;  84) 96-2573, UDI/DI 50649111061408, Lot codes:  SK-115, SK-130;  85) 96-2573A, UDI/DI 50649111487758, Lot codes:  HSI;  86) 96-2573M, UDI/DI 50649111276697, Lot codes:  SK-115, SK-116;  87) 96-2575, UDI/DI 50649111061644, Lot codes:  FSF9;  88) 96-2575A, UDI/DI 50649111487789, Lot codes:  SK-112;  89) 96-2576, UDI/DI 50649111061897, Lot codes:  FSF9;  90) 96-2578, UDI/DI 50649111062375, Lot codes:  724962578;  91) 96-2579, UDI/DI 50649111062542, Lot codes:  724962579;  92) 96-2579M, UDI/DI 50649111285576, Lot codes:  0724962579M;  93) 96-2588, UDI/DI 50649111064096, Lot codes:  SK-115;  94) 96-2620, UDI/DI 50649111070493, Lot codes:  SK-130;  95) 96-2622, UDI/DI 50649111070851, Lot codes:  SK-130, SK-131;  96) 96-2622A, UDI/DI 50649111487802, Lot codes:  SK-112;  97) 96-2623A, UDI/DI 50649111488205, Lot codes:  SK-112, SK-134;  98) 96-2624, UDI/DI 50649111071209, Lot codes:  FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25;  99) 96-2624A, UDI/DI 50649111488212, Lot codes:  SK-112;  100) 96-2626, UDI/DI 50649111071476, Lot codes:  FSF15, FSF22;  101) 96-2653, UDI/DI 50649111076525, Lot codes:  FSF8, FSF9, FSF18, FSF20, FSF24;  102) 96-2655, UDI/DI 50649111077027, Lot codes:  SK-115;  103) 96-2656, UDI/DI 50649111077072, Lot codes:  SK-115;  104) 96-2657, UDI/DI 50649111077232, Lot codes:  FSF8, FSF10;  105) 96-2658, UDI/DI 50649111077461, Lot codes:  FSF10, FSF17, FSF18, FSF24;  106) 96-2660, UDI/DI 50649111077928, Lot codes:  FST10, FST13;  107) 96-2661, UDI/DI 50649111078024, Lot codes:  724962661;  108) 96-2670, UDI/DI 50649111079588, Lot codes:  SK-115;  109) 96-2670M, UDI/DI 50649111034556, Lot codes:  0724962670M;  110) 96-2684, UDI/DI 50649111081703, Lot codes:  SK-116;  111) 96-2685, UDI/DI 50649111081857, Lot codes:  SK-116;  112) 96-2685A, UDI/DI 50649111488038, Lot codes:  60359;  113) 96-2687A, UDI/DI 50649111488311, Lot codes:  60431;  114) 96-2688, UDI/DI 50649111082335, Lot codes:  SK-115;  115) 96-2689, UDI/DI 50649111082472, Lot codes:  SK-116;  116) 96-2706, UDI/DI 50649111084995, Lot codes:  SK-130;  117) 96-2736A, UDI/DI 50649111487918, Lot codes:  SK-112;  118) 96-2737A, UDI/DI 50649111488106, Lot codes:  SK-112;  119) 96-2738A, UDI/DI 50649111487956, Lot codes:  SK-112;  120) 96-2739A, UDI/DI 50649111487963, Lot codes:  SK-112, SK-133;  121) 96-2764A, UDI/DI 50649111487871, Lot codes:  SK-112;  122) 96-2765, UDI/DI 50649111094185, Lot codes:  FST16;  123) 96-2772A, UDI/DI 50649111492585, Lot codes:  HSF26;  124) 96-2773A, UDI/DI 50649111492592, Lot codes:  SK-133, SK-134;  125) 96-2775, UDI/DI 50649111095793, Lot codes:  SK-115;  126) 96-2776A, UDI/DI 50649111492981, Lot codes:  SK-115;  127) 96-2777A, UDI/DI 50649111492974, Lot codes:  SK-115;  128) 96-2779A, UDI/DI 50649111492967, Lot codes:  SK-115;  129) 96-2785A, UDI/DI 50649111488076, Lot codes:  HSI;  130) 96-2786A, UDI/DI 50649111488083, Lot codes:  HSI;  131) 96-2787A, UDI/DI 50649111488090, Lot codes:  HSI;  132) 96-2790A, UDI/DI 50649111488250, Lot codes:  SK-112;  133) 96-2791A, UDI/DI 50649111488267, Lot codes:  SK-112;  134) 96-2795, UDI/DI 50649111488366, Lot codes:  FSF21, FSF24;  135) 96-2921, UDI/DI 50649111120525, Lot codes:  FST9;  136) 96-2921A, UDI/DI 50649111480865, Lot codes:  HSI;  137) 96-3006, UDI/DI 50649111134720, Lot codes:  FSF8, FSF9, FSF26;  138) 96-3010, UDI/DI 50649111135482, Lot codes:  FSF21;  139) 96-3015A, UDI/DI 50649111488182, Lot codes:  SK-112;  140) 96-3016A, UDI/DI 50649111488199, Lot codes:  SK-112;  141) 96-3020A, UDI/DI 50649111493179, Lot codes:  HST12;  142) 96-3023A, UDI/DI 50649111493209, Lot codes:  HST7;  143) 96-3025A, UDI/DI 50649111493223, Lot codes:  HST12;  144) 96-3030A, UDI/DI 50649111492998, Lot codes:  SK-134;  145) 96-3558A, UDI/DI 50649111487772, Lot codes:  SK-112;  146) 96-3560, UDI/DI 50649111440890, Lot codes:  SK-112, SK-131, SK-132;  147) 96-3560A, UDI/DI 50649111487765, Lot codes:  SK-112;  148) 96-3566A, UDI/DI 50649111492691, Lot codes:  SK-116;  149) 96-3615, UDI/DI 50649111449701, Lot codes:  FST10.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0939-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0939-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0939-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0939-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0939-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0939-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0939-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0939-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0939-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Sklar Instruments",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Reports of various packaging issues that may result in a breach of the sterile barrier.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-12-03",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) 94-0286, UDI/DI 50649111094406, Lot codes:  FSF21;  2) 94-0290, UDI/DI 50649111095045, Lot codes:  SK-115;  3) 94-0291, UDI/DI 50649111095144, Lot codes:  824940291, 924940291;  4) 941-0691, UDI/DI 50649111307902, Lot codes:  MST8, MST9;  5) 941-1414, UDI/DI 50649111464872, Lot codes:  SK-122;  6) 94-1924, UDI/DI 50649111345775, Lot codes:  FSF16, FSF22;  7) 94-5034, UDI/DI 50649111040687, Lot codes:  SK-112, SK-135;  8) 94-6146, UDI/DI 50649111215535, Lot codes:  SK-135;  9) 94-6616, UDI/DI 50649111287457, Lot codes:  SK-132;  10) 96-2215A, UDI/DI 50649111487567, Lot codes:  HSI;  11) 96-2289, UDI/DI 50649111439986, Lot codes:  SK-116;  12) 96-2293, UDI/DI 50649111440012, Lot codes:  SK-115, SK-132;  13) 96-2293A, UDI/DI 50649111487598, Lot codes:  HSI;  14) 96-2295A, UDI/DI 50649111493254, Lot codes:  HST21;  15) 96-2351, UDI/DI 50649111440081, Lot codes:  FST21;  16) 96-2386, UDI/DI 50649111440241, Lot codes:  FSF18;  17) 96-2406, UDI/DI 50649111035195, Lot codes:  FSF18, FSF24, FSF25;  18) 96-2408, UDI/DI 50649111035355, Lot codes:  FSF5, FSF12, FSF18, FSF26;  19) 96-2410, UDI/DI 50649111035669, Lot codes:  FST9;  20) 96-2412, UDI/DI 50649111035867, Lot codes:  FST6, FST9, FST10, FST11, FST12, FST20;  21) 96-2412A, UDI/DI 50649111487550, Lot codes:  SK-112;  22) 96-2412M, UDI/DI 50649111027015, Lot codes:  0724962412M;  23) 96-2450M, UDI/DI 50649111464483, Lot codes:  0624962450M;  24) 96-2461, UDI/DI 50649111440432, Lot codes:  SK-132;  25) 96-2462, UDI/DI 50649111464490, Lot codes:  SK-132;  26) 96-2470A, UDI/DI 50649111487970, Lot codes:  SK-112;  27) 96-2472A, UDI/DI 50649111487987, Lot codes:  SK-112;  28) 96-2515, UDI/DI 50649111050235, Lot codes:  SK-115;  29) 96-2515A, UDI/DI 50649111487857, Lot codes:  SK-112;  30) 96-2532, UDI/DI 50649111053212, Lot codes:  FSF8, FSF14;  31) 96-2533, UDI/DI 50649111053397, Lot codes:  FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23;  32) 96-2533A, UDI/DI 50649111487888, Lot codes:  HSI;  33) 96-2533M, UDI/DI 50649111215313, Lot codes:  SK-116;  34) 96-2534, UDI/DI 50649111478817, Lot codes:  FSF15, FSF21, FSF22, FSF23;  35) 96-2534A, UDI/DI 50649111492653, Lot codes:  HSF8, HSF18;  36) 96-2535A, UDI/DI 50649111488304, Lot codes:  SK-112;  37) 96-2536, UDI/DI 50649111054172, Lot codes:  FSF10, FSF21;  38) 96-2536M, UDI/DI 50649111220034, Lot codes:  0724962536M;  39) 96-2537, UDI/DI 50649111054424, Lot codes:  FSF5, FSF10;  40) 96-2537A, UDI/DI 50649111219496, Lot codes:  SK-112;  41) 96-2537M, UDI/DI 50649111221758, Lot codes:  0724962537M;  42) 96-2538, UDI/DI 50649111054639, Lot codes:  FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23;  43) 96-2539, UDI/DI 50649111054783, Lot codes:  FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24;  44) 96-2539A, UDI/DI 50649111487901, Lot codes:  SK-112;  45) 96-2539M, UDI/DI 50649111225336, Lot codes:  0724962539M;  46) 96-2544, UDI/DI 50649111056008, Lot codes:  FSF8, FSF10;  47) 96-2545, UDI/DI 50649111056183, Lot codes:  FSF10, FSF21;  48) 96-2547, UDI/DI 50649111056497, Lot codes:  FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26;  49) 96-2547A, UDI/DI 50649111236417, Lot codes:  SK-112, SK-136;  50) 96-2548, UDI/DI 50649111056725, Lot codes:  FSF12;  51) 96-2549, UDI/DI 50649111056800, Lot codes:  FSF8, FSF17, FSF26;  52) 96-2550, UDI/DI 50649111057135, Lot codes:  FSF9, FSF19, FSF22, FSF24;  53) 96-2551, UDI/DI 50649111057234, Lot codes:  FSF9, FSF20, FSF24, FSF25;  54) 96-2551A, UDI/DI 50649111487819, Lot codes:  SK-112;  55) 96-2552, UDI/DI 50649111057579, Lot codes:  FSF13, FSF14, FSF16, FSF21, FSF24;  56) 96-2552M, UDI/DI 50649111400818, Lot codes:  SK-133;  57) 96-2553, UDI/DI 50649111057715, Lot codes:  FSF5;  58) 96-2554, UDI/DI 50649111057814, Lot codes:  SK-134;  59) 96-2555, UDI/DI 50649111057982, Lot codes:  FSF19, FSF20, FSF26;  60) 96-2556, UDI/DI 50649111058248, Lot codes:  SK-131;  61) 96-2557, UDI/DI 50649111058545, Lot codes:  FSF19, FSF26;  62) 96-2558, UDI/DI 50649111058644, Lot codes:  SK-131;  63) 96-2559, UDI/DI 50649111058903, Lot codes:  SK-115;  64) 96-2559A, UDI/DI 50649111487635, Lot codes:  SK-112;  65) 96-2560, UDI/DI 50649111059078, Lot codes:  FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26;  66) 96-2561, UDI/DI 50649111059290, Lot codes:  FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24;  67) 96-2561A, UDI/DI 50649111488007, Lot codes:  SK-112;  68) 96-2561M, UDI/DI 50649111259041, Lot codes:  0724962561M;  69) 96-2562, UDI/DI 50649111059511, Lot codes:  FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26;  70) 96-2563, UDI/DI 50649111059733, Lot codes:  FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24;  71) 96-2563A, UDI/DI 50649111487994, Lot codes:  SK-112;  72) 96-2563M, UDI/DI 50649111262218, Lot codes:  0724962563M;  73) 96-2566A, UDI/DI 50649111488175, Lot codes:  SK-112;  74) 96-2568, UDI/DI 50649111060531, Lot codes:  FST13, FST21;  75) 96-2568A, UDI/DI 50649111267558, Lot codes:  SK-115;  76) 96-2569, UDI/DI 50649111060715, Lot codes:  FST9, FST10, FST21;  77) 96-2569A, UDI/DI 50649111487840, Lot codes:  HSI;  78) 96-2570, UDI/DI 50649111060845, Lot codes:  SK-115;  79) 96-2570M, UDI/DI 50649111271821, Lot codes:  SK-116;  80) 96-2571, UDI/DI 50649111061033, Lot codes:  SK-115;  81) 96-2571A, UDI/DI 50649111487642, Lot codes:  HSI;  82) 96-2571M, UDI/DI 50649111273498, Lot codes:  SK-116;  83) 96-2572, UDI/DI 50649111061187, Lot codes:  SK-115;  84) 96-2573, UDI/DI 50649111061408, Lot codes:  SK-115, SK-130;  85) 96-2573A, UDI/DI 50649111487758, Lot codes:  HSI;  86) 96-2573M, UDI/DI 50649111276697, Lot codes:  SK-115, SK-116;  87) 96-2575, UDI/DI 50649111061644, Lot codes:  FSF9;  88) 96-2575A, UDI/DI 50649111487789, Lot codes:  SK-112;  89) 96-2576, UDI/DI 50649111061897, Lot codes:  FSF9;  90) 96-2578, UDI/DI 50649111062375, Lot codes:  724962578;  91) 96-2579, UDI/DI 50649111062542, Lot codes:  724962579;  92) 96-2579M, UDI/DI 50649111285576, Lot codes:  0724962579M;  93) 96-2588, UDI/DI 50649111064096, Lot codes:  SK-115;  94) 96-2620, UDI/DI 50649111070493, Lot codes:  SK-130;  95) 96-2622, UDI/DI 50649111070851, Lot codes:  SK-130, SK-131;  96) 96-2622A, UDI/DI 50649111487802, Lot codes:  SK-112;  97) 96-2623A, UDI/DI 50649111488205, Lot codes:  SK-112, SK-134;  98) 96-2624, UDI/DI 50649111071209, Lot codes:  FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25;  99) 96-2624A, UDI/DI 50649111488212, Lot codes:  SK-112;  100) 96-2626, UDI/DI 50649111071476, Lot codes:  FSF15, FSF22;  101) 96-2653, UDI/DI 50649111076525, Lot codes:  FSF8, FSF9, FSF18, FSF20, FSF24;  102) 96-2655, UDI/DI 50649111077027, Lot codes:  SK-115;  103) 96-2656, UDI/DI 50649111077072, Lot codes:  SK-115;  104) 96-2657, UDI/DI 50649111077232, Lot codes:  FSF8, FSF10;  105) 96-2658, UDI/DI 50649111077461, Lot codes:  FSF10, FSF17, FSF18, FSF24;  106) 96-2660, UDI/DI 50649111077928, Lot codes:  FST10, FST13;  107) 96-2661, UDI/DI 50649111078024, Lot codes:  724962661;  108) 96-2670, UDI/DI 50649111079588, Lot codes:  SK-115;  109) 96-2670M, UDI/DI 50649111034556, Lot codes:  0724962670M;  110) 96-2684, UDI/DI 50649111081703, Lot codes:  SK-116;  111) 96-2685, UDI/DI 50649111081857, Lot codes:  SK-116;  112) 96-2685A, UDI/DI 50649111488038, Lot codes:  60359;  113) 96-2687A, UDI/DI 50649111488311, Lot codes:  60431;  114) 96-2688, UDI/DI 50649111082335, Lot codes:  SK-115;  115) 96-2689, UDI/DI 50649111082472, Lot codes:  SK-116;  116) 96-2706, UDI/DI 50649111084995, Lot codes:  SK-130;  117) 96-2736A, UDI/DI 50649111487918, Lot codes:  SK-112;  118) 96-2737A, UDI/DI 50649111488106, Lot codes:  SK-112;  119) 96-2738A, UDI/DI 50649111487956, Lot codes:  SK-112;  120) 96-2739A, UDI/DI 50649111487963, Lot codes:  SK-112, SK-133;  121) 96-2764A, UDI/DI 50649111487871, Lot codes:  SK-112;  122) 96-2765, UDI/DI 50649111094185, Lot codes:  FST16;  123) 96-2772A, UDI/DI 50649111492585, Lot codes:  HSF26;  124) 96-2773A, UDI/DI 50649111492592, Lot codes:  SK-133, SK-134;  125) 96-2775, UDI/DI 50649111095793, Lot codes:  SK-115;  126) 96-2776A, UDI/DI 50649111492981, Lot codes:  SK-115;  127) 96-2777A, UDI/DI 50649111492974, Lot codes:  SK-115;  128) 96-2779A, UDI/DI 50649111492967, Lot codes:  SK-115;  129) 96-2785A, UDI/DI 50649111488076, Lot codes:  HSI;  130) 96-2786A, UDI/DI 50649111488083, Lot codes:  HSI;  131) 96-2787A, UDI/DI 50649111488090, Lot codes:  HSI;  132) 96-2790A, UDI/DI 50649111488250, Lot codes:  SK-112;  133) 96-2791A, UDI/DI 50649111488267, Lot codes:  SK-112;  134) 96-2795, UDI/DI 50649111488366, Lot codes:  FSF21, FSF24;  135) 96-2921, UDI/DI 50649111120525, Lot codes:  FST9;  136) 96-2921A, UDI/DI 50649111480865, Lot codes:  HSI;  137) 96-3006, UDI/DI 50649111134720, Lot codes:  FSF8, FSF9, FSF26;  138) 96-3010, UDI/DI 50649111135482, Lot codes:  FSF21;  139) 96-3015A, UDI/DI 50649111488182, Lot codes:  SK-112;  140) 96-3016A, UDI/DI 50649111488199, Lot codes:  SK-112;  141) 96-3020A, UDI/DI 50649111493179, Lot codes:  HST12;  142) 96-3023A, UDI/DI 50649111493209, Lot codes:  HST7;  143) 96-3025A, UDI/DI 50649111493223, Lot codes:  HST12;  144) 96-3030A, UDI/DI 50649111492998, Lot codes:  SK-134;  145) 96-3558A, UDI/DI 50649111487772, Lot codes:  SK-112;  146) 96-3560, UDI/DI 50649111440890, Lot codes:  SK-112, SK-131, SK-132;  147) 96-3560A, UDI/DI 50649111487765, Lot codes:  SK-112;  148) 96-3566A, UDI/DI 50649111492691, Lot codes:  SK-116;  149) 96-3615, UDI/DI 50649111449701, Lot codes:  FST10.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic: Nationwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}