{
  "@context": {
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    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0646-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL HYST FFX, REF DYNJ63631A;   24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   25) LAVH PACK, REF DYNJ67210A;   26) VAG MINOR PACK, REF DYNJ82216;   27) VAG MINOR PACK, REF DYNJ82216B;   28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F;   29) VAGINAL, REF DYNJ900292K;   30) GYN LAPAROTOMY, REF DYNJ900296J;   31) LAVH, REF DYNJ900298J;   32) LAVH, REF DYNJ900298K;   33) LITHOTOMY-LF, REF DYNJ900721C;   34) MAJOR VAGINAL-LF, REF DYNJ901807I;   35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F;   36) VAGINAL HYST, REF DYNJ907220A;   37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792;   38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795;   39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B;   40) PRENTICE VAG HYST KIT, REF DYNJ908796;   41) PRENTICE VAG HYST KIT, REF DYNJ908796B;   42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825;   43) KIT PFANNENSTIEL GYN, REF DYNJ908826;   44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837",
  "description": "FDA recall Z-0646-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL HYST FFX, REF DYNJ63631A;   24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   25) LAVH PACK, REF DYNJ67210A;   26) VAG MINOR PACK, REF DYNJ82216;   27) VAG MINOR PACK, REF DYNJ82216B;   28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F;   29) VAGINAL, REF DYNJ900292K;   30) GYN LAPAROTOMY, REF DYNJ900296J;   31) LAVH, REF DYNJ900298J;   32) LAVH, REF DYNJ900298K;   33) LITHOTOMY-LF, REF DYNJ900721C;   34) MAJOR VAGINAL-LF, REF DYNJ901807I;   35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F;   36) VAGINAL HYST, REF DYNJ907220A;   37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792;   38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795;   39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B;   40) PRENTICE VAG HYST KIT, REF DYNJ908796;   41) PRENTICE VAG HYST KIT, REF DYNJ908796B;   42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825;   43) KIT PFANNENSTIEL GYN, REF DYNJ908826;   44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837 (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"
    }
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0646-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL HYST FFX, REF DYNJ63631A;   24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   25) LAVH PACK, REF DYNJ67210A;   26) VAG MINOR PACK, REF DYNJ82216;   27) VAG MINOR PACK, REF DYNJ82216B;   28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F;   29) VAGINAL, REF DYNJ900292K;   30) GYN LAPAROTOMY, REF DYNJ900296J;   31) LAVH, REF DYNJ900298J;   32) LAVH, REF DYNJ900298K;   33) LITHOTOMY-LF, REF DYNJ900721C;   34) MAJOR VAGINAL-LF, REF DYNJ901807I;   35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F;   36) VAGINAL HYST, REF DYNJ907220A;   37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792;   38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795;   39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B;   40) PRENTICE VAG HYST KIT, REF DYNJ908796;   41) PRENTICE VAG HYST KIT, REF DYNJ908796B;   42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825;   43) KIT PFANNENSTIEL GYN, REF DYNJ908826;   44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0646-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0646-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL HYST FFX, REF DYNJ63631A;   24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   25) LAVH PACK, REF DYNJ67210A;   26) VAG MINOR PACK, REF DYNJ82216;   27) VAG MINOR PACK, REF DYNJ82216B;   28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F;   29) VAGINAL, REF DYNJ900292K;   30) GYN LAPAROTOMY, REF DYNJ900296J;   31) LAVH, REF DYNJ900298J;   32) LAVH, REF DYNJ900298K;   33) LITHOTOMY-LF, REF DYNJ900721C;   34) MAJOR VAGINAL-LF, REF DYNJ901807I;   35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F;   36) VAGINAL HYST, REF DYNJ907220A;   37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792;   38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795;   39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B;   40) PRENTICE VAG HYST KIT, REF DYNJ908796;   41) PRENTICE VAG HYST KIT, REF DYNJ908796B;   42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825;   43) KIT PFANNENSTIEL GYN, REF DYNJ908826;   44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837",
      "text": "The FDA logged enforcement record Z-0646-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL HYST FFX, REF DYNJ63631A;   24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B;   25) LAVH PACK, REF DYNJ67210A;   26) VAG MINOR PACK, REF DYNJ82216;   27) VAG MINOR PACK, REF DYNJ82216B;   28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F;   29) VAGINAL, REF DYNJ900292K;   30) GYN LAPAROTOMY, REF DYNJ900296J;   31) LAVH, REF DYNJ900298J;   32) LAVH, REF DYNJ900298K;   33) LITHOTOMY-LF, REF DYNJ900721C;   34) MAJOR VAGINAL-LF, REF DYNJ901807I;   35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F;   36) VAGINAL HYST, REF DYNJ907220A;   37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792;   38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795;   39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B;   40) PRENTICE VAG HYST KIT, REF DYNJ908796;   41) PRENTICE VAG HYST KIT, REF DYNJ908796B;   42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825;   43) KIT PFANNENSTIEL GYN, REF DYNJ908826;   44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837 — reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-09. Affected lots/codes: 85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers:  24BBQ489, 23KBP697;  2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers:  22LDA249, 23CDB670, 23JDA480, 23IDA660;  3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers:  24ADA431, 24BDB524;  4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers:  24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697;  5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers:  22LDB323, 22LDC130, 23CDA546;  6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers:  23IBT540;  7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers:  22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599;  8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers:  22FMH645, 22HMF692;  9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers:  23DMD053;  10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers:  23FMC422;  11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers:  22EBR089, 23ABM013, 23CBX286;  12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers:  23JDA425, 23GDB694, 23JDA783;  13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers:  22HMF864, 23EMB913;  14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers:  23LMC975, 23LMC305, 24AMC175, 23FMD871;  15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers:  23IBR215;  16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers:  22IDA312, 22LDB966;  17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers:  23ADA450, 23CDC113, 23CDA613, 23BDA189;  18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315;  19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers:  22KDB784, 22LDA872, 22LDB908, 23DDA086;  20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers:  22FBN014, 22LBP709, 23DBJ770, 23CBF613;  21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers:  23IBN858;  22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers:  22DBL296, 22FBS033;  23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers:  22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757;  24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers:  23ABQ738;  25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers:  22GBY195, 22GBO568;  26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers:  23HMI516;  27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers:  23JMG567;  28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers:  23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601;  29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers:  22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068;  30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers:  22GBT650, 23DBA294, 23EBG706;  31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers:  22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389;  32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers:  23GBM311;  33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers:  22EBO945, 22HBE990, 23ABQ354, 22LBE624, 22KBC673, 23EBV945;  34) REF DYNJ901807I, UDI/DI 10195327496166 (each) 40195327496167 (case), Lot Numbers:  23KDB594, 23IDC225, 24CDB873, 24BDB761;  35) REF DYNJ906478F, UDI/DI 10195327202675 (each) 40195327202676 (case), Lot Numbers:  23GDB463, 23IDB304;  36) REF DYNJ907220A, UDI/DI 10195327329648 (each) 40195327329649 (case), Lot Numbers:  23BME638;  37) REF DYNJ908792, UDI/DI 10195327183264 (each) 40195327183265 (case), Lot Numbers:  23CDA683;  38) REF DYNJ908795, UDI/DI 10195327183288 (each) 40195327183289 (case), Lot Numbers:  23DDB794, 23FDB261, 23JDB336;  39) REF DYNJ908795B, UDI/DI 10195327535049 (each) 40195327535040 (case), Lot Numbers:  24AMA320, 24BMK237, 24AMH044;  40) REF DYNJ908796, UDI/DI 10195327183271 (each) 40195327183272 (case), Lot Numbers:  23IDA364, 23EDA172;  41) REF DYNJ908796B, UDI/DI 10195327535056 (each) 40195327535057 (case), Lot Numbers:  23LMF165;  42) REF DYNJ908825, UDI/DI 10195327185121 (each) 40195327185122 (case), Lot Numbers:  23BDA825, 23EDC464;  43) REF DYNJ908826, UDI/DI 10195327185145 (each) 40195327185146 (case), Lot Numbers:  22LDA975;  44) REF DYNJ908837, UDI/DI 10195327185169 (each) 40195327185160 (case), Lot Numbers:  23IDB086, 23JDA593, 23HDB464, 23HDB110. 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-0646-2025&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-0646-2025&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-0646-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0646-2025 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-0646-2025&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-0646-2025&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-0646-2025/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."
    }
  ],
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0646-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0646-2025",
            "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-09",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers:  24BBQ489, 23KBP697;  2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers:  22LDA249, 23CDB670, 23JDA480, 23IDA660;  3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers:  24ADA431, 24BDB524;  4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers:  24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697;  5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers:  22LDB323, 22LDC130, 23CDA546;  6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers:  23IBT540;  7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers:  22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599;  8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers:  22FMH645, 22HMF692;  9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers:  23DMD053;  10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers:  23FMC422;  11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers:  22EBR089, 23ABM013, 23CBX286;  12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers:  23JDA425, 23GDB694, 23JDA783;  13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers:  22HMF864, 23EMB913;  14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers:  23LMC975, 23LMC305, 24AMC175, 23FMD871;  15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers:  23IBR215;  16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers:  22IDA312, 22LDB966;  17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers:  23ADA450, 23CDC113, 23CDA613, 23BDA189;  18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315;  19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers:  22KDB784, 22LDA872, 22LDB908, 23DDA086;  20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers:  22FBN014, 22LBP709, 23DBJ770, 23CBF613;  21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers:  23IBN858;  22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers:  22DBL296, 22FBS033;  23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers:  22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757;  24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers:  23ABQ738;  25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers:  22GBY195, 22GBO568;  26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers:  23HMI516;  27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers:  23JMG567;  28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers:  23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601;  29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers:  22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068;  30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers:  22GBT650, 23DBA294, 23EBG706;  31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers:  22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389;  32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers:  23GBM311;  33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers:  22EBO945, 22HBE990, 23ABQ354, 22LBE624, 22KBC673, 23EBV945;  34) REF DYNJ901807I, UDI/DI 10195327496166 (each) 40195327496167 (case), Lot Numbers:  23KDB594, 23IDC225, 24CDB873, 24BDB761;  35) REF DYNJ906478F, UDI/DI 10195327202675 (each) 40195327202676 (case), Lot Numbers:  23GDB463, 23IDB304;  36) REF DYNJ907220A, UDI/DI 10195327329648 (each) 40195327329649 (case), Lot Numbers:  23BME638;  37) REF DYNJ908792, UDI/DI 10195327183264 (each) 40195327183265 (case), Lot Numbers:  23CDA683;  38) REF DYNJ908795, UDI/DI 10195327183288 (each) 40195327183289 (case), Lot Numbers:  23DDB794, 23FDB261, 23JDB336;  39) REF DYNJ908795B, UDI/DI 10195327535049 (each) 40195327535040 (case), Lot Numbers:  24AMA320, 24BMK237, 24AMH044;  40) REF DYNJ908796, UDI/DI 10195327183271 (each) 40195327183272 (case), Lot Numbers:  23IDA364, 23EDA172;  41) REF DYNJ908796B, UDI/DI 10195327535056 (each) 40195327535057 (case), Lot Numbers:  23LMF165;  42) REF DYNJ908825, UDI/DI 10195327185121 (each) 40195327185122 (case), Lot Numbers:  23BDA825, 23EDC464;  43) REF DYNJ908826, UDI/DI 10195327185145 (each) 40195327185146 (case), Lot Numbers:  22LDA975;  44) REF DYNJ908837, UDI/DI 10195327185169 (each) 40195327185160 (case), Lot Numbers:  23IDB086, 23JDA593, 23HDB464, 23HDB110",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}