{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@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-0089-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile;  (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile;  (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile;  (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile;  (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile;  (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile;  (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile;  (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile;  (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile;  (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile;  (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile;  (27) Presource Complex Spine Pack, Cat. SNE12NS388,  Sterile;  (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile;  (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile;  (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile;  (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile;  (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile;  (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile;  (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile;  (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile;  (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile;  (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile;  (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile;  (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile;  (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile;  (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile;  (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile;  (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile;  (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile;  (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile;  (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and   (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.",
  "description": "FDA recall Z-0089-2024 — Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile;  (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile;  (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile;  (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile;  (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile;  (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile;  (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile;  (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile;  (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile;  (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile;  (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile;  (27) Presource Complex Spine Pack, Cat. SNE12NS388,  Sterile;  (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile;  (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile;  (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile;  (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile;  (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile;  (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile;  (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile;  (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile;  (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile;  (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile;  (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile;  (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile;  (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile;  (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile;  (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile;  (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile;  (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile;  (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile;  (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and   (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile. (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-0089-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile;  (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile;  (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile;  (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile;  (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile;  (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile;  (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile;  (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile;  (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile;  (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile;  (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile;  (27) Presource Complex Spine Pack, Cat. SNE12NS388,  Sterile;  (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile;  (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile;  (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile;  (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile;  (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile;  (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile;  (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile;  (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile;  (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile;  (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile;  (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile;  (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile;  (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile;  (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile;  (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile;  (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile;  (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile;  (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile;  (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and   (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0089-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0089-2024: Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile;  (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile;  (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile;  (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile;  (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile;  (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile;  (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile;  (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile;  (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile;  (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile;  (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile;  (27) Presource Complex Spine Pack, Cat. SNE12NS388,  Sterile;  (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile;  (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile;  (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile;  (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile;  (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile;  (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile;  (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile;  (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile;  (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile;  (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile;  (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile;  (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile;  (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile;  (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile;  (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile;  (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile;  (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile;  (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile;  (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and   (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.",
      "text": "The FDA logged enforcement record Z-0089-2024: Cardinal Health 200, LLC is voluntarily recalling Procedure packs:    (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile;  (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile;  (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile;  (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile;  (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile;  (6) Presource PBDS Cat. PN40CD806,  Kit, Pedi C D, RWJ, Sterile;  (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile;  (8) Presource PBDS Cat. PN73APVD7,  Kit, Neuro Spine Module, Sterile;  (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile;  (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile;  (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile;  (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile;  (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile;  (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile;  (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile;  (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile;  (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile;  (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile;  (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile;  (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile;  (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile;  (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile;  (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile;  (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile;  (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile;  (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile;  (27) Presource Complex Spine Pack, Cat. SNE12NS388,  Sterile;  (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile;  (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile;  (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile;  (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile;  (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile;  (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile;  (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile;  (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile;  (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile;  (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile;  (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile;  (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile;  (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile;  (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile;  (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile;  (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile;  (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile;  (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile;  (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and   (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile. — reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-16. Affected lots/codes: (1) Cat. PNVMNIB21 - Lot #920364, Exp. 6/1/2024, UDI-DI 10195594891879;  (2) Cat. PN08LAG13 - Lot #920368, Exp. 6/1/2024, UDI-DI 10195594886516;  (3) Cat. PN08LAG17 - Lot #987136, Exp. 11/1/2024, UDI-DI 10197106132944;  (4) Cat. PN11SFS40 - Lot #917897, Exp. 6/1/2024, UDI-DI 10195594875060; (5) Cat. PN33DBOU3 - Lot #918902, Exp. 8/1/2023, UDI-DI 10195594878627;  (6) Cat. PN40CD806 - Lot #17765, Exp. 5/1/2024, UDI-DI 10197106202968;  (7) Cat. PN73APVDE - Lot #936774, Exp. 9/1/2023, UDI-DI 10195594742065;  (8) Cat. PN73APVD7 - Lot #931972, Exp. 9/1/2023, UDI-DI 10197106016787;  (9) Cat. POHFSPMHC - Lot #929330, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903096;  (10) Cat. SAN73PPTAC - Lot #964384, Exp. 6/1/2025, UDI-DI 10888439008166;  (11) Cat. SNECGLPCOB - Lot #917630, Exp. 6/1/2024, UDI-DI 10195594560942;  (12) Cat. SNECGNSEBF - Lot #940134, Exp. 8/1/2024, UDI-DI 10197106002537;  (13) Cat. SNECGNSEB4 - Lot #990736, Exp. 11/1/2024, UDI-DI 10197106143315;  (14) Cat. SNECGSPAUH - Lot #923838, Exp. 4/1/2024, UDI-DI 10195594271480;  (15) Cat. SNECGSPSGG - Lot #17548, Exp. 11/1/2024 and Exp. 5/1/2024, UDI-DI 10197106131572;  (16) Cat. SNEDKCSWDB - Lot #977629, Exp. 10/1/2024, UDI-DI  10197106029800; (17) Cat. SNEDKLLFLF - Lot #917621, Exp. 5/1/2024 and Exp. 11/1/2024, UDI-DI 10195594948528;  (18) Cat. SNEHDNSRVJ - Lot #18167, Exp. 5/1/2024, UDI-DI 10888439902938;  (19) Cat. SNEOCLPLSC - Lot #16886, Exp. 5/1/2025, UDI-DI 10195594963200;  (20) Cat. SNEOCNPNBC - Lot #922662, Exp. 1/1/2024, UDI-DI 10887488974897;  (21) Cat. SNE11LMENX - Lot #918521, Exp. 6/1/2024, UDI-DI 10195594736026;  (22) Cat. SNE11SPDML - Lot #923218, Exp. 9/1/2023, UDI-DI 10195594433482;  (23) Cat. SNE12ACGTY - Lot #16589, Exp. 6/1/2024, UDI-DI 10888439665093;  (24) Cat. SNE12LM33J - Lot #923782, Exp. 4/1/2024, UDI-DI 10888439665116;  (25) Cat. SNE12LM348 - Lot #992523, Exp. 7/1/2024, UDI-DI 10197106150399;  (26) Cat. SNE12LM349 - Lot #997471, Exp. 12/1/2024, UDI-DI 10197106162149;  (27) Cat. SNE12NS388 - Lot #987470, Exp. 12/1/2024, UDI-DI 10197106134146;  (28) Cat. SNE12SPHMS - Lot #923360, Exp. 7/1/2024, UDI-DI 10195594660895;  (29) Cat. SNE23SPGTH - Lot #999249, Exp. 1/1/2025, UDI-DI 10197106078150;  (30) Cat. SNE33NROUE - Lot #919347, Exp. 12/1/2024, UDI-DI 10195594792558;  (31) Cat. SNE33SPO11 - Lot #941910, Exp. 9/1/2024, UDI-DI 10197106034149;  (32) Cat. SNE35NABLD - Lot #922223, Exp. 6/1/2025, UDI-DI 10888439939651;  (33) Cat. SNE40SPPCH - Lot #48287, Exp. 12/1/2023 and Exp. 7/1/2024, UDI-DI 10195594455033;  (34) Cat. SNE41NBCSE - Lot #990152, Exp. 10/1/2024, UDI-DI 10888439916355;  (35) Cat. SNE41NBCS9 - Lot #919989, Exp. 7/1/2024, UDI-DI 10195594880538;  (36) Cat. SNE43LNOG6 - Lot #34812, Exp. 5/1/2024, UDI-DI 10197106250495;  (37) Cat. SNE51NBMRL - Lot #932527, Exp. 8/1/2024, UDI-DI 10888439575125;  (38) Cat. SNE53NEFCH - Lot #24957, Exp. 5/1/2024 and Exp. 8/1/2024, UDI-DI 10195594368593;  (39) Cat. SNE53SFVMF - Lot #986877, Exp. 2/1/2024, UDI-DI 10195594764562;  (40) Cat. SNE57NP00A - Lot #930583, Exp. 7/1/2024, UDI-DI 10195594512552;  (41) Cat. SNE57SPKPX - Lot #929434, Exp. 10/1/2024 and Exp. 7/1/2024, UDI-DI 10195594075507;  (42) Cat. SNE69SPFRL - Lot #931449 Exp. 7/1/2024, UDI-DI 10195594447519;  (43) Cat. SNE73NSCTJ - Lot #986478, Exp. 11/1/2024, UDI-DI 10195594678562;  (44) Cat. SNE73SPKFL - Lot #950758, Exp. 8/1/2024, UDI-DI 10888439662986; (45) Cat. SNE73SPTAC - Lot #900047, Exp. 5/1/2024 and Exp. 6/1/2024, UDI-DI 10888439136975;  (46) Cat. SNE81ACNMN - Lot #17214, Exp. 4/1/2025, and Lot #D221752, Exp. 5/1/2024, UDI-DI  10195594733018; and (47) Cat. SNE81ULNMO - Lot #931699, Exp. 5/1/2024, UDI-DI 10888439934113.. 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-0089-2024&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-0089-2024&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-0089-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0089-2024 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-0089-2024&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-0089-2024&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-0089-2024/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0089-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0089-2024",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "(1) Cat. PNVMNIB21 - Lot #920364, Exp. 6/1/2024, UDI-DI 10195594891879;  (2) Cat. PN08LAG13 - Lot #920368, Exp. 6/1/2024, UDI-DI 10195594886516;  (3) Cat. PN08LAG17 - Lot #987136, Exp. 11/1/2024, UDI-DI 10197106132944;  (4) Cat. PN11SFS40 - Lot #917897, Exp. 6/1/2024, UDI-DI 10195594875060; (5) Cat. PN33DBOU3 - Lot #918902, Exp. 8/1/2023, UDI-DI 10195594878627;  (6) Cat. PN40CD806 - Lot #17765, Exp. 5/1/2024, UDI-DI 10197106202968;  (7) Cat. PN73APVDE - Lot #936774, Exp. 9/1/2023, UDI-DI 10195594742065;  (8) Cat. PN73APVD7 - Lot #931972, Exp. 9/1/2023, UDI-DI 10197106016787;  (9) Cat. POHFSPMHC - Lot #929330, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903096;  (10) Cat. SAN73PPTAC - Lot #964384, Exp. 6/1/2025, UDI-DI 10888439008166;  (11) Cat. SNECGLPCOB - Lot #917630, Exp. 6/1/2024, UDI-DI 10195594560942;  (12) Cat. SNECGNSEBF - Lot #940134, Exp. 8/1/2024, UDI-DI 10197106002537;  (13) Cat. SNECGNSEB4 - Lot #990736, Exp. 11/1/2024, UDI-DI 10197106143315;  (14) Cat. SNECGSPAUH - Lot #923838, Exp. 4/1/2024, UDI-DI 10195594271480;  (15) Cat. SNECGSPSGG - Lot #17548, Exp. 11/1/2024 and Exp. 5/1/2024, UDI-DI 10197106131572;  (16) Cat. SNEDKCSWDB - Lot #977629, Exp. 10/1/2024, UDI-DI  10197106029800; (17) Cat. SNEDKLLFLF - Lot #917621, Exp. 5/1/2024 and Exp. 11/1/2024, UDI-DI 10195594948528;  (18) Cat. SNEHDNSRVJ - Lot #18167, Exp. 5/1/2024, UDI-DI 10888439902938;  (19) Cat. SNEOCLPLSC - Lot #16886, Exp. 5/1/2025, UDI-DI 10195594963200;  (20) Cat. SNEOCNPNBC - Lot #922662, Exp. 1/1/2024, UDI-DI 10887488974897;  (21) Cat. SNE11LMENX - Lot #918521, Exp. 6/1/2024, UDI-DI 10195594736026;  (22) Cat. SNE11SPDML - Lot #923218, Exp. 9/1/2023, UDI-DI 10195594433482;  (23) Cat. SNE12ACGTY - Lot #16589, Exp. 6/1/2024, UDI-DI 10888439665093;  (24) Cat. SNE12LM33J - Lot #923782, Exp. 4/1/2024, UDI-DI 10888439665116;  (25) Cat. SNE12LM348 - Lot #992523, Exp. 7/1/2024, UDI-DI 10197106150399;  (26) Cat. SNE12LM349 - Lot #997471, Exp. 12/1/2024, UDI-DI 10197106162149;  (27) Cat. SNE12NS388 - Lot #987470, Exp. 12/1/2024, UDI-DI 10197106134146;  (28) Cat. SNE12SPHMS - Lot #923360, Exp. 7/1/2024, UDI-DI 10195594660895;  (29) Cat. SNE23SPGTH - Lot #999249, Exp. 1/1/2025, UDI-DI 10197106078150;  (30) Cat. SNE33NROUE - Lot #919347, Exp. 12/1/2024, UDI-DI 10195594792558;  (31) Cat. SNE33SPO11 - Lot #941910, Exp. 9/1/2024, UDI-DI 10197106034149;  (32) Cat. SNE35NABLD - Lot #922223, Exp. 6/1/2025, UDI-DI 10888439939651;  (33) Cat. SNE40SPPCH - Lot #48287, Exp. 12/1/2023 and Exp. 7/1/2024, UDI-DI 10195594455033;  (34) Cat. SNE41NBCSE - Lot #990152, Exp. 10/1/2024, UDI-DI 10888439916355;  (35) Cat. SNE41NBCS9 - Lot #919989, Exp. 7/1/2024, UDI-DI 10195594880538;  (36) Cat. SNE43LNOG6 - Lot #34812, Exp. 5/1/2024, UDI-DI 10197106250495;  (37) Cat. SNE51NBMRL - Lot #932527, Exp. 8/1/2024, UDI-DI 10888439575125;  (38) Cat. SNE53NEFCH - Lot #24957, Exp. 5/1/2024 and Exp. 8/1/2024, UDI-DI 10195594368593;  (39) Cat. SNE53SFVMF - Lot #986877, Exp. 2/1/2024, UDI-DI 10195594764562;  (40) Cat. SNE57NP00A - Lot #930583, Exp. 7/1/2024, UDI-DI 10195594512552;  (41) Cat. SNE57SPKPX - Lot #929434, Exp. 10/1/2024 and Exp. 7/1/2024, UDI-DI 10195594075507;  (42) Cat. SNE69SPFRL - Lot #931449 Exp. 7/1/2024, UDI-DI 10195594447519;  (43) Cat. SNE73NSCTJ - Lot #986478, Exp. 11/1/2024, UDI-DI 10195594678562;  (44) Cat. SNE73SPKFL - Lot #950758, Exp. 8/1/2024, UDI-DI 10888439662986; (45) Cat. SNE73SPTAC - Lot #900047, Exp. 5/1/2024 and Exp. 6/1/2024, UDI-DI 10888439136975;  (46) Cat. SNE81ACNMN - Lot #17214, Exp. 4/1/2025, and Lot #D221752, Exp. 5/1/2024, UDI-DI  10195594733018; and (47) Cat. SNE81ULNMO - Lot #931699, Exp. 5/1/2024, UDI-DI 10888439934113.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV.  There was government distribution and no military distribution. The country of Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}