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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3028-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;   2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;   3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;   4) LACERATION TRAY , Pack Number DYNDL1495A ;   5) LACERATION TRAY , Pack Number DYNDL1495AH;   6) LACERATION TRAY , Pack Number DYNDL1807B ;   7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;   8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;   9) LACERATION TRAY , Pack Number DYNDL1965A ;   10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;   11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;   12) LACERATION TRAY , Pack Number DYNDL1981;   13) LACERATION TRAY , Pack Number DYNDL1985;   14) SUTURE TRAY , Pack Number DYNDL1986;   15) FGH FLOOR KIT , Pack Number DYNDL1989;   16) LACERATION KIT, Pack Number DYNDL1991;   17) LACERATION KIT, Pack Number DYNDL1992;   18) LACERATION KIT, Pack Number DYNDL1992H ;   19) ER LACERATION TRAY, Pack Number DYNDL1993;   20) LACERATION TRAY , Pack Number DYNDL1994;   21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;   22) CLOSING BUNDLE, Pack Number DYNJ52157I ;   23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;   24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;   25) CLOSING PACK, Pack Number DYNJ57577A ;   26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;   27) CLOSING PACK, Pack Number DYNJ68267B ;   28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;   29) PREP TRAY , Pack Number DYNJRA1583D;   30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;   31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;   32) IR SUTURE PACK-LF , Pack Number PHS863717D ;   33) FINE LACERATION KIT , Pack Number SUT17215A;   34) MINOR LACERATION TRAY , Pack Number SUT18200 ;   35) LACERATION TRAY, Pack Number SUT20285A;   36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;   37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;   38) LACERATION TRAY , Pack Number SUT21710 ;   39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;   40) SNAG FREE LACERATION TRAY , Pack Number SUT21825",
  "description": "FDA recall Z-3028-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;   2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;   3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;   4) LACERATION TRAY , Pack Number DYNDL1495A ;   5) LACERATION TRAY , Pack Number DYNDL1495AH;   6) LACERATION TRAY , Pack Number DYNDL1807B ;   7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;   8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;   9) LACERATION TRAY , Pack Number DYNDL1965A ;   10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;   11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;   12) LACERATION TRAY , Pack Number DYNDL1981;   13) LACERATION TRAY , Pack Number DYNDL1985;   14) SUTURE TRAY , Pack Number DYNDL1986;   15) FGH FLOOR KIT , Pack Number DYNDL1989;   16) LACERATION KIT, Pack Number DYNDL1991;   17) LACERATION KIT, Pack Number DYNDL1992;   18) LACERATION KIT, Pack Number DYNDL1992H ;   19) ER LACERATION TRAY, Pack Number DYNDL1993;   20) LACERATION TRAY , Pack Number DYNDL1994;   21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;   22) CLOSING BUNDLE, Pack Number DYNJ52157I ;   23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;   24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;   25) CLOSING PACK, Pack Number DYNJ57577A ;   26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;   27) CLOSING PACK, Pack Number DYNJ68267B ;   28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;   29) PREP TRAY , Pack Number DYNJRA1583D;   30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;   31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;   32) IR SUTURE PACK-LF , Pack Number PHS863717D ;   33) FINE LACERATION KIT , Pack Number SUT17215A;   34) MINOR LACERATION TRAY , Pack Number SUT18200 ;   35) LACERATION TRAY, Pack Number SUT20285A;   36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;   37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;   38) LACERATION TRAY , Pack Number SUT21710 ;   39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;   40) SNAG FREE LACERATION TRAY , Pack Number SUT21825 (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.",
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  "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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3028-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;   2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;   3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;   4) LACERATION TRAY , Pack Number DYNDL1495A ;   5) LACERATION TRAY , Pack Number DYNDL1495AH;   6) LACERATION TRAY , Pack Number DYNDL1807B ;   7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;   8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;   9) LACERATION TRAY , Pack Number DYNDL1965A ;   10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;   11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;   12) LACERATION TRAY , Pack Number DYNDL1981;   13) LACERATION TRAY , Pack Number DYNDL1985;   14) SUTURE TRAY , Pack Number DYNDL1986;   15) FGH FLOOR KIT , Pack Number DYNDL1989;   16) LACERATION KIT, Pack Number DYNDL1991;   17) LACERATION KIT, Pack Number DYNDL1992;   18) LACERATION KIT, Pack Number DYNDL1992H ;   19) ER LACERATION TRAY, Pack Number DYNDL1993;   20) LACERATION TRAY , Pack Number DYNDL1994;   21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;   22) CLOSING BUNDLE, Pack Number DYNJ52157I ;   23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;   24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;   25) CLOSING PACK, Pack Number DYNJ57577A ;   26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;   27) CLOSING PACK, Pack Number DYNJ68267B ;   28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;   29) PREP TRAY , Pack Number DYNJRA1583D;   30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;   31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;   32) IR SUTURE PACK-LF , Pack Number PHS863717D ;   33) FINE LACERATION KIT , Pack Number SUT17215A;   34) MINOR LACERATION TRAY , Pack Number SUT18200 ;   35) LACERATION TRAY, Pack Number SUT20285A;   36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;   37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;   38) LACERATION TRAY , Pack Number SUT21710 ;   39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;   40) SNAG FREE LACERATION TRAY , Pack Number SUT21825",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3028-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3028-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;   2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;   3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;   4) LACERATION TRAY , Pack Number DYNDL1495A ;   5) LACERATION TRAY , Pack Number DYNDL1495AH;   6) LACERATION TRAY , Pack Number DYNDL1807B ;   7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;   8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;   9) LACERATION TRAY , Pack Number DYNDL1965A ;   10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;   11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;   12) LACERATION TRAY , Pack Number DYNDL1981;   13) LACERATION TRAY , Pack Number DYNDL1985;   14) SUTURE TRAY , Pack Number DYNDL1986;   15) FGH FLOOR KIT , Pack Number DYNDL1989;   16) LACERATION KIT, Pack Number DYNDL1991;   17) LACERATION KIT, Pack Number DYNDL1992;   18) LACERATION KIT, Pack Number DYNDL1992H ;   19) ER LACERATION TRAY, Pack Number DYNDL1993;   20) LACERATION TRAY , Pack Number DYNDL1994;   21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;   22) CLOSING BUNDLE, Pack Number DYNJ52157I ;   23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;   24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;   25) CLOSING PACK, Pack Number DYNJ57577A ;   26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;   27) CLOSING PACK, Pack Number DYNJ68267B ;   28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;   29) PREP TRAY , Pack Number DYNJRA1583D;   30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;   31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;   32) IR SUTURE PACK-LF , Pack Number PHS863717D ;   33) FINE LACERATION KIT , Pack Number SUT17215A;   34) MINOR LACERATION TRAY , Pack Number SUT18200 ;   35) LACERATION TRAY, Pack Number SUT20285A;   36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;   37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;   38) LACERATION TRAY , Pack Number SUT21710 ;   39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;   40) SNAG FREE LACERATION TRAY , Pack Number SUT21825",
      "text": "The FDA logged enforcement record Z-3028-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;   2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;   3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;   4) LACERATION TRAY , Pack Number DYNDL1495A ;   5) LACERATION TRAY , Pack Number DYNDL1495AH;   6) LACERATION TRAY , Pack Number DYNDL1807B ;   7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;   8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;   9) LACERATION TRAY , Pack Number DYNDL1965A ;   10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;   11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;   12) LACERATION TRAY , Pack Number DYNDL1981;   13) LACERATION TRAY , Pack Number DYNDL1985;   14) SUTURE TRAY , Pack Number DYNDL1986;   15) FGH FLOOR KIT , Pack Number DYNDL1989;   16) LACERATION KIT, Pack Number DYNDL1991;   17) LACERATION KIT, Pack Number DYNDL1992;   18) LACERATION KIT, Pack Number DYNDL1992H ;   19) ER LACERATION TRAY, Pack Number DYNDL1993;   20) LACERATION TRAY , Pack Number DYNDL1994;   21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;   22) CLOSING BUNDLE, Pack Number DYNJ52157I ;   23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;   24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;   25) CLOSING PACK, Pack Number DYNJ57577A ;   26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;   27) CLOSING PACK, Pack Number DYNJ68267B ;   28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;   29) PREP TRAY , Pack Number DYNJRA1583D;   30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;   31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;   32) IR SUTURE PACK-LF , Pack Number PHS863717D ;   33) FINE LACERATION KIT , Pack Number SUT17215A;   34) MINOR LACERATION TRAY , Pack Number SUT18200 ;   35) LACERATION TRAY, Pack Number SUT20285A;   36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;   37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;   38) LACERATION TRAY , Pack Number SUT21710 ;   39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;   40) SNAG FREE LACERATION TRAY , Pack Number SUT21825 — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: DYKMBNDL200A , Lot Number 22KBD675 ;  DYKMBNDL200A , Lot Number 23KBA331 ;  DYKMBNDL200AH, Lot Number 22KBD675 ;  DYKMBNDL200AH, Lot Number 23KBA331 ;  DYNDA2415B , Lot Number 23JLA114 ;  DYNDA2415B , Lot Number 24BLB045 ;  DYNDL1495A , Lot Number 22LBJ768 ;  DYNDL1495A , Lot Number 23ABG899 ;  DYNDL1495A , Lot Number 23CBF146 ;  DYNDL1495A , Lot Number 23DBO301 ;  DYNDL1495A , Lot Number 23EBC524 ;  DYNDL1495A , Lot Number 23EBR564 ;  DYNDL1495A , Lot Number 23GBC601 ;  DYNDL1495A , Lot Number 23HBF407 ;  DYNDL1495A , Lot Number 23IBR368 ;  DYNDL1495A , Lot Number 23KBF026 ;  DYNDL1495AH, Lot Number 22LBJ768 ;  DYNDL1495AH, Lot Number 23ABG899 ;  DYNDL1495AH, Lot Number 23CBF146 ;  DYNDL1495AH, Lot Number 23DBO301 ;  DYNDL1495AH, Lot Number 23EBC524 ;  DYNDL1495AH, Lot Number 23EBR564 ;  DYNDL1495AH, Lot Number 23GBC601 ;  DYNDL1495AH, Lot Number 23HBF407 ;  DYNDL1495AH, Lot Number 23IBR368 ;  DYNDL1495AH, Lot Number 23KBF026 ;  DYNDL1807B , Lot Number 21JBR532 ;  DYNDL1963, Lot Number 22JMG284 ;  DYNDL1963H , Lot Number 22JMG284 ;  DYNDL1965A , Lot Number 21JBJ528 ;  DYNDL1980A, Lot Number 23KBE409;  DYNDL1980AH, Lot Number 23KBE409;  DYNDL1981, Lot Number 22GBU753 ;  DYNDL1981, Lot Number 22LBS274 ;  DYNDL1981, Lot Number 23ABL575 ;  DYNDL1981, Lot Number 23BBJ949 ;  DYNDL1981, Lot Number 23CBG983 ;  DYNDL1985, Lot Number 22JBN831 ;  DYNDL1985, Lot Number 23CBQ478 ;  DYNDL1985, Lot Number 23DBF367 ;  DYNDL1986, Lot Number 22LBJ084 ;  DYNDL1986, Lot Number 23FBO474 ;  DYNDL1986, Lot Number 23GBE045 ;  DYNDL1989, Lot Number 23DBN197 ;  DYNDL1989, Lot Number 23FBB552 ;  DYNDL1989, Lot Number 23GBR197 ;  DYNDL1991, Lot Number 23IMG395 ;  DYNDL1992, Lot Number 23IBH341 ;  DYNDL1992, Lot Number 23KBA670 ;  DYNDL1992H , Lot Number 23IBH341 ;  DYNDL1992H , Lot Number 23KBA670 ;  DYNDL1993, Lot Number 23JBP617 ;  DYNDL1994, Lot Number 23KBF825 ;  DYNDL1994, Lot Number 23LBV214 ;  DYNJ0807503N , Lot Number 23FME235 ;  DYNJ52157I , Lot Number 23EBQ422 ;  DYNJ52157I , Lot Number 23FBO768 ;  DYNJ52157I , Lot Number 23HBG369 ;  DYNJ52157I , Lot Number 23KBJ323 ;  DYNJ54326A , Lot Number 23AME179 ;  DYNJ54326A , Lot Number 23AME557 ;  DYNJ56987C , Lot Number 22ABW610 ;  DYNJ56987C , Lot Number 22DBL196 ;  DYNJ56987C , Lot Number 22FBT303 ;  DYNJ56987C , Lot Number 22GBV087 ;  DYNJ56987C , Lot Number 22HBA077 ;  DYNJ56987C , Lot Number 22HBG952 ;  DYNJ56987C , Lot Number 22JBP791 ;  DYNJ56987C , Lot Number 23DBR364 ;  DYNJ56987C , Lot Number 23EBO053 ;  DYNJ56987C , Lot Number 23FBJ914 ;  DYNJ57577A , Lot Number 23KBB899 ;  DYNJ67429B , Lot Number 23HBM022 ;  DYNJ67429B , Lot Number 23LBH577 ;  DYNJ68267B , Lot Number 23JBS852 ;  DYNJ68267B , Lot Number 23LBC084 ;  DYNJ80585B , Lot Number 23JBO457 ;  DYNJRA1583D, Lot Number 23BBO987 ;  DYNJRA1583D, Lot Number 23CBK029 ;  DYNJRA1583D, Lot Number 23DBO695 ;  DYNJRA1583D, Lot Number 23EBQ098 ;  DYNJRA1583D, Lot Number 23GBE489 ;  DYNJRA1583D, Lot Number 23HBT552 ;  DYNJRA1583D, Lot Number 23JBM501 ;  DYNJRA1583D, Lot Number 23JBO381 ;  DYNJRA1583D, Lot Number 23JBW239 ;  M101498, Lot Number 23FBL279 ;  M101498, Lot Number 23HBT746 ;  M101498, Lot Number 23IBM609 ;  M101498, Lot Number 23JBY348 ;  PHS751688G, Lot Number 22GME957;  PHS751688G , Lot Number 22JME303 ;  PHS751688G , Lot Number 22LMA157 ;  PHS751688G , Lot Number 23EMC745 ;  PHS751688G , Lot Number 23GMF501 ;  PHS751688G , Lot Number 23HMI688 ;  PHS751688G , Lot Number 23IMI261 ;  PHS751688G , Lot Number 23LMG060 ;  PHS863717D , Lot Number 23HMA623 ;  SUT17215A, Lot Number 21JBR416 ;  SUT17215A, Lot Number 21LBD248 ;  SUT17215A, Lot Number 21LBH077 ;  SUT17215A, Lot Number 22ABU681 ;  SUT17215A, Lot Number 22BBH582 ;  SUT17215A, Lot Number 22FBV156 ;  SUT17215A, Lot Number 22GBD888 ;  SUT17215A, Lot Number 22HBN609 ;  SUT17215A, Lot Number 22KBG540 ;  SUT17215A, Lot Number 23FBF413 ;  SUT17215A, Lot Number 23IBD809 ;  SUT17215A, Lot Number 23IBM566 ;  SUT17215A, Lot Number 23KBL557 ;  SUT18200 , Lot Number 22FBT088 ;  SUT18200 , Lot Number 22GBL911 ;  SUT18200 , Lot Number 22HBJ926 ;  SUT20285A, Lot Number 23LBS386;  SUT20285A, Lot Number 23JBS506;  SUT20285A, Lot Number 23IBI056;  SUT20285A, Lot Number 23GBW843;  SUT20285A, Lot Number 23FBE166;  SUT20285A, Lot Number 23EBU296;  SUT20285A, Lot Number 23LBS386;  SUT20285A, Lot Number 23JBS506;  SUT20285A, Lot Number 23IBI056;  SUT20285A, Lot Number 23GBW843;  SUT20285A, Lot Number 23FBE166;  SUT20285A, Lot Number 23EBU296;  SUT20595A, Lot Number 24ABC621;  SUT20595A, Lot Number 23JBQ538;  SUT20595A, Lot Number 23HBK602;  SUT20595A, Lot Number 23FBR371;  SUT20595A, Lot Number 23DBE268;  SUT20595A, Lot Number 23ABS718;  SUT21665, Lot Number 24ABU830;  SUT21665, Lot Number 23HBW402;  SUT21665, Lot Number 22LBM554;  SUT21665, Lot Number 22LBH669;  SUT21665, Lot Number 22BBP538;  SUT21710 , Lot Number 22EBP025 ;  SUT21710 , Lot Number 22KBU033 ;  SUT21710 , Lot Number 22LBO669 ;  SUT21710 , Lot Number 23EBA694 ;  SUT21710 , Lot Number 23FBK814 ;  SUT21710 , Lot Number 23HBU140 ;  SUT21710 , Lot Number 23KBO838 ;  SUT21710 , Lot Number 23KBV154 ;  SUT21780 , Lot Number 23HBJ842 ;  SUT21825 , Lot Number 23JBM130. 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-3028-2024&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-3028-2024&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-3028-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3028-2024 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-3028-2024&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-3028-2024&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."
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      "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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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      "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."
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