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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1444-2024.jsonld",
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  "name": "Centurion manual surgical kits labeled as:   a) STERILE 4-1/2\" S/S SCISSOR (SS5031), Product Code 65145;   b) STERILE S/B SCISSOR 4-1/2\" (I142), Product Code 65940;   c) STERILE S/B SCISSOR 5-1/2\" (I140), Product Code 65945;   d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150;   e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155;   f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215;   g) STERILE 5-1/2\" S/S SCISSOR (SS507), Product Code 66260;   h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350;   i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365;   j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450;   k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465;   l) STERILE CURV MAYO SCISSOR 5 1/2\" (81310), Product Code 66665;   m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710;   n) STERILE 6 1/2\" S/B SCISSOR (11109SB), Product Code 66820;   o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845;   p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885;   q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890;   r) STERILE CURVED METZENBAUM (ST142), Product Code 66895;   s) STERILE B/B SCISSOR 6 1/2\", Product Code 66995;   t) STERILE 6 3/4\" MAYO SCISSOR, Product Code 67160;   u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165;   v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185;   w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450;   x) STERILE 51/2\" EPISIOTOMY SCISSOR (11140), Product Code 67645;   y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650;   z) STERILE REPROCESSED 6 1/2\" S/B SCISSOR, Product Code 66820K;   aa) ST METZENBAUM SCISSOR CURVED 9\"(MBS90C), Product Code I68510;   bb) ST UMBILICAL SCISSOR, CRVD, 4\" (11148), Product Code I68575;   cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790;   dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600;   ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K;   ff) STERILE STR MAYO SCISSOR 5 1/2\" (ST115), Product Code TRI67630    MEDLINE:  MEDLINE manual surgical kits labeled as:    a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000;   b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133",
  "description": "FDA recall Z-1444-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion manual surgical kits labeled as:   a) STERILE 4-1/2\" S/S SCISSOR (SS5031), Product Code 65145;   b) STERILE S/B SCISSOR 4-1/2\" (I142), Product Code 65940;   c) STERILE S/B SCISSOR 5-1/2\" (I140), Product Code 65945;   d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150;   e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155;   f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215;   g) STERILE 5-1/2\" S/S SCISSOR (SS507), Product Code 66260;   h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350;   i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365;   j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450;   k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465;   l) STERILE CURV MAYO SCISSOR 5 1/2\" (81310), Product Code 66665;   m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710;   n) STERILE 6 1/2\" S/B SCISSOR (11109SB), Product Code 66820;   o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845;   p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885;   q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890;   r) STERILE CURVED METZENBAUM (ST142), Product Code 66895;   s) STERILE B/B SCISSOR 6 1/2\", Product Code 66995;   t) STERILE 6 3/4\" MAYO SCISSOR, Product Code 67160;   u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165;   v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185;   w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450;   x) STERILE 51/2\" EPISIOTOMY SCISSOR (11140), Product Code 67645;   y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650;   z) STERILE REPROCESSED 6 1/2\" S/B SCISSOR, Product Code 66820K;   aa) ST METZENBAUM SCISSOR CURVED 9\"(MBS90C), Product Code I68510;   bb) ST UMBILICAL SCISSOR, CRVD, 4\" (11148), Product Code I68575;   cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790;   dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600;   ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K;   ff) STERILE STR MAYO SCISSOR 5 1/2\" (ST115), Product Code TRI67630    MEDLINE:  MEDLINE manual surgical kits labeled as:    a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000;   b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133 (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centurion manual surgical kits labeled as:   a) STERILE 4-1/2\" S/S SCISSOR (SS5031), Product Code 65145;   b) STERILE S/B SCISSOR 4-1/2\" (I142), Product Code 65940;   c) STERILE S/B SCISSOR 5-1/2\" (I140), Product Code 65945;   d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150;   e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155;   f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215;   g) STERILE 5-1/2\" S/S SCISSOR (SS507), Product Code 66260;   h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350;   i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365;   j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450;   k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465;   l) STERILE CURV MAYO SCISSOR 5 1/2\" (81310), Product Code 66665;   m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710;   n) STERILE 6 1/2\" S/B SCISSOR (11109SB), Product Code 66820;   o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845;   p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885;   q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890;   r) STERILE CURVED METZENBAUM (ST142), Product Code 66895;   s) STERILE B/B SCISSOR 6 1/2\", Product Code 66995;   t) STERILE 6 3/4\" MAYO SCISSOR, Product Code 67160;   u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165;   v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185;   w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450;   x) STERILE 51/2\" EPISIOTOMY SCISSOR (11140), Product Code 67645;   y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650;   z) STERILE REPROCESSED 6 1/2\" S/B SCISSOR, Product Code 66820K;   aa) ST METZENBAUM SCISSOR CURVED 9\"(MBS90C), Product Code I68510;   bb) ST UMBILICAL SCISSOR, CRVD, 4\" (11148), Product Code I68575;   cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790;   dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600;   ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K;   ff) STERILE STR MAYO SCISSOR 5 1/2\" (ST115), Product Code TRI67630    MEDLINE:  MEDLINE manual surgical kits labeled as:    a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000;   b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1444-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1444-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion manual surgical kits labeled as:   a) STERILE 4-1/2\" S/S SCISSOR (SS5031), Product Code 65145;   b) STERILE S/B SCISSOR 4-1/2\" (I142), Product Code 65940;   c) STERILE S/B SCISSOR 5-1/2\" (I140), Product Code 65945;   d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150;   e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155;   f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215;   g) STERILE 5-1/2\" S/S SCISSOR (SS507), Product Code 66260;   h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350;   i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365;   j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450;   k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465;   l) STERILE CURV MAYO SCISSOR 5 1/2\" (81310), Product Code 66665;   m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710;   n) STERILE 6 1/2\" S/B SCISSOR (11109SB), Product Code 66820;   o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845;   p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885;   q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890;   r) STERILE CURVED METZENBAUM (ST142), Product Code 66895;   s) STERILE B/B SCISSOR 6 1/2\", Product Code 66995;   t) STERILE 6 3/4\" MAYO SCISSOR, Product Code 67160;   u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165;   v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185;   w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450;   x) STERILE 51/2\" EPISIOTOMY SCISSOR (11140), Product Code 67645;   y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650;   z) STERILE REPROCESSED 6 1/2\" S/B SCISSOR, Product Code 66820K;   aa) ST METZENBAUM SCISSOR CURVED 9\"(MBS90C), Product Code I68510;   bb) ST UMBILICAL SCISSOR, CRVD, 4\" (11148), Product Code I68575;   cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790;   dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600;   ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K;   ff) STERILE STR MAYO SCISSOR 5 1/2\" (ST115), Product Code TRI67630    MEDLINE:  MEDLINE manual surgical kits labeled as:    a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000;   b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133",
      "text": "The FDA logged enforcement record Z-1444-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Centurion manual surgical kits labeled as:   a) STERILE 4-1/2\" S/S SCISSOR (SS5031), Product Code 65145;   b) STERILE S/B SCISSOR 4-1/2\" (I142), Product Code 65940;   c) STERILE S/B SCISSOR 5-1/2\" (I140), Product Code 65945;   d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150;   e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155;   f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215;   g) STERILE 5-1/2\" S/S SCISSOR (SS507), Product Code 66260;   h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350;   i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365;   j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450;   k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465;   l) STERILE CURV MAYO SCISSOR 5 1/2\" (81310), Product Code 66665;   m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710;   n) STERILE 6 1/2\" S/B SCISSOR (11109SB), Product Code 66820;   o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845;   p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885;   q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890;   r) STERILE CURVED METZENBAUM (ST142), Product Code 66895;   s) STERILE B/B SCISSOR 6 1/2\", Product Code 66995;   t) STERILE 6 3/4\" MAYO SCISSOR, Product Code 67160;   u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165;   v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185;   w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450;   x) STERILE 51/2\" EPISIOTOMY SCISSOR (11140), Product Code 67645;   y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650;   z) STERILE REPROCESSED 6 1/2\" S/B SCISSOR, Product Code 66820K;   aa) ST METZENBAUM SCISSOR CURVED 9\"(MBS90C), Product Code I68510;   bb) ST UMBILICAL SCISSOR, CRVD, 4\" (11148), Product Code I68575;   cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790;   dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600;   ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K;   ff) STERILE STR MAYO SCISSOR 5 1/2\" (ST115), Product Code TRI67630    MEDLINE:  MEDLINE manual surgical kits labeled as:    a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000;   b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133 — reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-23. Affected lots/codes: a) 65145, UDI/DI 60653160023758 (case) 00653160023756 (each), Lot Numbers:  2023071990, 2023100390;   b) 65940, UDI/DI 70653160018805 (case) 00653160018806 (each), Lot Numbers:  2023112290;   c) 65945, UDI/DI 60653160024823 (case) 00653160024821 (each), Lot Numbers:  2023041290, 2023042890, 2023050190, 2023051890, 2023051990, 2023052290, 2023052490, 2023052590, 2023062090, 2023071490, 2023071790, 2023090290, 2023110190;   d) 66150, UDI/DI 60653160023765 (case) 00653160023763 (each), Lot Numbers:  2023041390, 2023071490, 2023091890, 2023101190;   e) 66155, UDI/DI 70653160022970 (case) 00653160022971 (each), Lot Numbers: 2023030390, 2023032990, 2023033090, 2023041890, 2023071090;    f) 66215, UDI/DI 60653160004863 (case) 00653160004861 (each), Lot Numbers: 2023052690, 2023102790;    g) 66260, UDI/DI 60653160008366 (case) 00653160008364 (each), Lot Numbers:  2023022290;   h) 66350, UDI/DI 50653160018306 (case) 00653160018301 (each), Lot Numbers:  2023062790, 2023091190;   i) 66365, UDI/DI 10653160025672 (case) 00653160025675 (each), Lot Numbers:  2023041990, 2023072890;   j) 66450, UDI/DI 60653160022348 (case) 00653160022346 (each), Lot Numbers:  2023022890, 2023030190;   k) 66465, UDI/DI 10653160023067 (case) 00653160023060 (each), Lot Numbers:  2023063090;   l) 66665, UDI/DI 60653160082717 (case) 00653160082715 (each), Lot Numbers:  2023061490, 2023071990, 2023100690;   m) 66710, UDI/DI 70653160046341 (case) 00653160046342 (each), Lot Numbers:  2023111090;   n) 66820, UDI/DI 60653160028289 (case) 00653160028287 (each), Lot Numbers:  2023061490, 2023101890;   o) 66845, UDI/DI 60653160048058 (case) 00653160048056 (each), Lot Numbers:  2023090190;   p) 66885, UDI/DI 50653160049256 (case) 00653160049251 (each), Lot Numbers:  2023030990;   q) 66890, UDI/DI 60653160049246 (case) 00653160049244 (each), Lot Numbers:  2023040690, 2023041090, 2023100990;   r) 66895, UDI/DI 50653160006563 (case) 00653160006568 (each), Lot Numbers:  2023102690;   s) 66995, UDI/DI 60653160048393 (case) 00653160048391 (each), Lot Numbers:  2023032390, 2023110390;   t) 67160, UDI/DI 50653160052195 (case) 00653160052190 (each), Lot Numbers: 2023032790;   u) 67165, UDI/DI 60653160046962 (case) 00653160046960 (each), Lot Numbers:  2023030390;   v) 67185, UDI/DI 60653160038745 (case) 00653160038743 (each), Lot Numbers:  2023042590, 2023112290;   w) 67450, UDI/DI 30653160134989 (case) 00653160134988 (each), Lot Numbers:  2023100690;   x) 67645, UDI/DI 30653160195850 (case) 00653160195859 (each), Lot Numbers:  2023021490, 2023060790, 2023112790;   y) 67650, UDI/DI 30653160195867 (case) 00653160195866 (each), Lot Numbers:  2023030390;   z) 66820K, UDI/DI 00653160351408 (case) 10653160351405 (each), Lot Numbers:  2023050890 (not distributed)  aa) I68510, UDI/DI 00653160293074 (case) 10653160293071 (each), Lot Numbers:  2023031390, 2023091890;   bb) I68575, UDI/DI 00653160306675 (case) 10653160306672 (each), Lot Numbers:  2023022290, 2023041190, 2023060790;   cc) I68790, UDI/DI 00653160327656 (case) 10653160327653 (each), Lot Numbers:  2023101890, 2023111690;   dd) TRI66600, UDI/DI 00653160317992 (case) 10653160317999 (each), Lot Numbers:  2023021490, 2023041190;   ee) TRI66670K, UDI/DI 00653160358667 (case) 10653160358664 (each), Lot Numbers:  2023030990, 2023040690;   ff) TRI67630, UDI/DI 00653160317923 (case) 10653160317920 (each), Lot Numbers:  2023100690, 2023112790;   MEDLINE:  a) DYND04000, UDI/DI 20193489191346 (case) 10193489191349 (each), Lot Numbers: 2023021490, 2023050390, 2023050590, 2023050790, 2023051090, 2023050690, 2023050890, 2023050990, 2023051190, 2023051290, 2023051390, 2023051690, 2023050490, 2023051890, 2023051990, 2023052090, 2023052290, 2023052390, 2023052590, 2023052690, 2023052790, 2023052990, 2023053090, 2023060190, 2023060490, 2023060790, 2023060990, 2023061090, 2023061390, 2023061490, 2023061590, 2023070690, 2023081790, 2023081890, 2023101690, 2023102490, 2023102590, 2023102790, 2023102890, 2023102690, 2023112290, 2023112390, 2023110790;    b) DYND04133, UDI/DI 20193489191360 (case) 10193489191363 (each), Lot Numbers: 2023033190, 2023101890. 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-1444-2024&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-1444-2024&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-1444-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1444-2024 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-1444-2024&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-1444-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1444-2024/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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      "name": "FDA recall details — Z-1444-2024",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1444-2024",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        },
        {
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
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            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-02-23",
            "Status": "recorded"
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        },
        {
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          "position": 8,
          "item": {
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            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Panama, Canada.",
            "Status": "recorded"
          }
        }
      ]
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}