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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1357-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:  Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):  10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;  10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;  10UN10A, 10.0MM UNCUFF TRACH TUBE X1;  10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;  10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;  4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;  4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;  4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;  4UN65A, 6.5MM UNCUFF TRACH TUBE X1;  4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;  4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;  5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;  5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;  5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;  5UN70A, 7.0MM UNCUFF TRACH TUBE X1;  5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;  5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;  6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;  6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;  6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;  6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;  6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;  7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;  7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;  7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;  7UN80A, 8.0MM UNCUFF TRACH TUBE X1;  7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;  7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;  8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;  8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;  8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;  8UN85A, 8.5MM UNCUFF TRACH TUBE X1;  8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;  8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;  9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;  9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;  9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;  9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1",
  "description": "FDA recall Z-1357-2023 — Covidien is recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:  Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):  10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;  10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;  10UN10A, 10.0MM UNCUFF TRACH TUBE X1;  10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;  10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;  4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;  4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;  4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;  4UN65A, 6.5MM UNCUFF TRACH TUBE X1;  4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;  4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;  5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;  5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;  5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;  5UN70A, 7.0MM UNCUFF TRACH TUBE X1;  5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;  5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;  6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;  6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;  6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;  6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;  6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;  7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;  7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;  7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;  7UN80A, 8.0MM UNCUFF TRACH TUBE X1;  7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;  7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;  8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;  8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;  8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;  8UN85A, 8.5MM UNCUFF TRACH TUBE X1;  8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;  8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;  9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;  9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;  9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;  9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1 (Devices, Class I). 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",
  "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-1357-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:  Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):  10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;  10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;  10UN10A, 10.0MM UNCUFF TRACH TUBE X1;  10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;  10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;  4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;  4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;  4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;  4UN65A, 6.5MM UNCUFF TRACH TUBE X1;  4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;  4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;  5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;  5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;  5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;  5UN70A, 7.0MM UNCUFF TRACH TUBE X1;  5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;  5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;  6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;  6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;  6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;  6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;  6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;  7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;  7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;  7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;  7UN80A, 8.0MM UNCUFF TRACH TUBE X1;  7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;  7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;  8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;  8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;  8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;  8UN85A, 8.5MM UNCUFF TRACH TUBE X1;  8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;  8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;  9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;  9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;  9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;  9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Covidien"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1357-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1357-2023: Covidien is recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:  Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):  10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;  10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;  10UN10A, 10.0MM UNCUFF TRACH TUBE X1;  10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;  10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;  4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;  4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;  4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;  4UN65A, 6.5MM UNCUFF TRACH TUBE X1;  4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;  4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;  5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;  5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;  5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;  5UN70A, 7.0MM UNCUFF TRACH TUBE X1;  5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;  5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;  6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;  6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;  6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;  6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;  6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;  7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;  7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;  7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;  7UN80A, 8.0MM UNCUFF TRACH TUBE X1;  7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;  7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;  8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;  8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;  8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;  8UN85A, 8.5MM UNCUFF TRACH TUBE X1;  8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;  8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;  9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;  9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;  9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;  9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1",
      "text": "The FDA logged enforcement record Z-1357-2023: Covidien is voluntarily recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:  Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):  10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;  10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF;  10UN10A, 10.0MM UNCUFF TRACH TUBE X1;  10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;  10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS;  4CN65A, 6.5MM TRACH TUBE W TG CUFF X1;  4CN65H, 6.5MM SHILEY CUFFED TRACH CANN;  4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1;  4UN65A, 6.5MM UNCUFF TRACH TUBE X1;  4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA;  4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1;  5CN70A, 7.0MM TRACH TUBE W TG CUFF X1;  5CN70H, 7.0MM SHILEY CUFFED TRACH CANN;  5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1;  5UN70A, 7.0MM UNCUFF TRACH TUBE X1;  5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA;  5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1;  6CN75A, 7.5MM TRACH TUBE W TG CUFF X1;  6CN75H, 7.5MM SHILEY CUFFED TRACH CANN;  6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1;  6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA;  6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1;  7CN80A, 8.0MM TRACH TUBE W TG CUFF X1;  7CN80H, 8.0MM SHILEY CUFFED TRACH CANN;  7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1;  7UN80A, 8.0MM UNCUFF TRACH TUBE X1;  7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA;  7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1;  8CN85A, 8.5MM TRACH TUBE W TG CUFF X1;  8CN85H, 8.5MM SHILEY CUFFED TRACH CANN;  8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1;  8UN85A, 8.5MM UNCUFF TRACH TUBE X1;  8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA;  8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1;  9CN90H, 9.0MM SHILEY CUFFED TRACH CANN;  9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1;  9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA;  9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1 — reason: A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-24. Affected lots/codes: REF/UDI-DI/Lot: 10CN10H/10884521172371/21C0402JZX, 21D0461JZX, 21G0457JZX, 21I0293JZX, 21I0294JZX, 21I0552JZX, 21J1435JZX, 21J1436JZX, 21K0275JZX, 21K0276JZX, 21K0277JZX, 21K0278JZX;  10CN10R/10884521205475/202107218X, 202107296X, 202108128X, 202108285X, 21H0792JZX, 21H0793JZX, 21H0794JZX, 22I0596JZX;  10UN10A/20884521175690/21D0463JZX;  10UN10H/20884521176291/21E0661JZX, 21G0473JZX;  10UN10R/10884521205543/202105307X, 202105308X, 202106148X, 202209335X;  4CN65A/10884521172456/21C0432JZX, 21I0369JZX;  4CN65H/20884521176307/21C0358JZX, 21C0359JZX, 21C0360JZX, 21C0361JZX, 21D0440JZX, 21D0441JZX, 21E0512JZX, 21E0513JZX, 21E0514JZX, 21E0515JZX, 21E0516JZX, 21E0517JZX, 21E0518JZX, 21E0519JZX, 21E0520JZX, 21E0521JZX, 21E0522JZX, 21E0523JZX, 21E0524JZX, 21E0525JZX, 21E0526JZX, 21E0527JZX, 21E1773JZX, 21E1774JZX, 21E1775JZX, 21E1776JZX, 21E1777JZX, 21E1778JZX, 21E1779JZX, 21E1780JZX, 21E1781JZX, 21E1782JZX, 21E1783JZX, 21H1324JZX, 21J0181JZX, 21J1094JZX, 21K0237JZX, 21K0239JZX, 21K0639JZX, 21K0643JZX, 21K0645JZX, 22C1465JZX, 22C1466JZX, 22C1467JZX, 22D0798JZX, 22D0799JZX, 22D0800JZX, 22D0801JZX, 22D0891JZX, 22D0892JZX, 22D0893JZX, 22D0897JZX, 22D0898JZX, 22D0899JZX, 22D0900JZX, 22D0901JZX, 22D0909JZX, 22F0918JZX, 22F0919JZX, 22F0920JZX, 22F0921JZX, 22F0922JZX, 22F0923JZX, 22F0924JZX, 22F0925JZX, 22F0926JZX, 22F0927JZX, 22F0928JZX, 22F0929JZX, 22J0073JZX, 22J0074JZX, 22J0075JZX, 22J0076JZX, 22J0077JZX, 22J0080JZX, 22J0081JZX, 22J0083JZX;  4CN65R/10884521205024/202105082X, 202105310X, 202106267X, 202106268X, 202107294X, 202107295X, 202111088X, 202111270X, 202111399X, 202112135X, 202201303X, 202202186X;  4UN65A/20884521175706/21D0466JZX, 21E0659JZX, 21E0660JZX;  4UN65H/20884521176239/21C0413JZX, 21C0414JZX, 21C0416JZX, 21C0417JZX, 21D0898JZX, 21D0899JZX, 21D0900JZX, 21D0901JZX, 21E1784JZX, 21E1785JZX, 22D0930JZX, 22D0931JZX, 22D0932JZX, 22D0933JZX, 22E0679JZX, 22E0680JZX;  4UN65R/10884521205482/202107297X, 202107298X, 202107299X, 202107300X, 202108122X, 202108123X, 202108124X, 202108125X, 202108139X, 202108140X, 202108228X, 202108229X, 21E1139JZX;  5CN70A/10884521172463/22D0927JZX, 22D0928JZX, 22D0929JZX, 22H0031JZX, 22H0032JZX, 22H0033JZX, 22H0860JZX, 22H0861JZX, 22H0863JZX, 22H0865JZX, 22J0071JZX, 22J0072JZX;  5CN70H/20884521176314/21C0404JZX, 21C0405JZX, 21C0406JZX, 21D0462JZX, 21G1130JZX, 21I0283JZX, 21I0284JZX, 21I0285JZX, 21I0286JZX, 21I0519JZX, 21I0520JZX, 21I0521JZX, 21I0522JZX, 21I0544JZX, 21I0545JZX, 21I0546JZX, 21I0630JZX, 21I0631JZX, 22D0924JZX, 22D0925JZX, 22D0926JZX, 22H0152JZX;  5CN70R/10884521205420/202111135X, 202208294X, 202208295X, 202210208X;  5UN70A/20884521175713/21B0062JZX, 21E0645JZX, 21E0646JZX, 21E0647JZX;  5UN70H/20884521176246/21E0655JZX, 21E0656JZX, 21G1008JZX, 21G1009JZX, 21H0735JZX;  5UN70R/10884521205499/202208296X;  6CN75A/10884521172470/22A0137JZX, 22H0868JZX;  6CN75H/20884521176321/21D0420JZX, 21D0421JZX, 21D0422JZX, 21D0423JZX, 21D0424JZX, 21D0425JZX, 21D0426JZX, 21D0427JZX, 21D0428JZX, 21D0429JZX, 21D0430JZX, 21D0431JZX, 21D0432JZX, 21D0433JZX, 21D0434JZX, 21D0435JZX, 21D0436JZX, 21D0437JZX, 21D0438JZX, 21D0439JZX, 21D0741JZX, 21D0742JZX, 21D0743JZX, 21D0744JZX, 21D0745JZX, 21D0746JZX, 21D0747JZX, 21D0748JZX, 21D0749JZX, 21E0632JZX, 21E0633JZX, 21E0634JZX, 21E0635JZX, 21E0636JZX, 21E0637JZX, 21E0638JZX, 21E0639JZX, 21E0640JZX, 21E0641JZX, 21E0642JZX, 21E0643JZX, 21E0644JZX, 21E1100JZX, 21E1101JZX, 21E1673JZX, 21E1674JZX, 21E1675JZX, 21E1676JZX, 21E1677JZX, 21E1678JZX, 21E1679JZX, 21E1680JZX, 21E1681JZX, 21E1682JZX, 21E1683JZX, 21E1684JZX, 21E1685JZX, 21E1686JZX, 21E1687JZX, 21E1688JZX, 21E1689JZX, 21E1690JZX, 21E1691JZX, 21E1694JZX, 21E1695JZX, 21E1696JZX, 21E1697JZX, 21E1769JZX, 21F0692JZX, 21F0693JZX, 21F0694JZX, 21G0296JZX, 21G0297JZX, 21G0298JZX, 21G0299JZX, 21G0426JZX, 21G0427JZX, 21G0428JZX, 21G0429JZX, 21G0430JZX, 21H0624JZX, 21I0260JZX, 21I0261JZX, 21I0262JZX, 21I0263JZX, 21I0264JZX, 21I0265JZX, 21I0266JZX, 21I0267JZX, 21I0268JZX, 21I0269JZX, 21I0270JZX, 21I0271JZX, 21I0491JZX, 21I0492JZX, 21I0680JZX, 21I0681JZX, 21I0682JZX, 21I0683JZX, 21J0090JZX, 21J0168JZX, 21J0169JZX, 21J0170JZX, 21J0171JZX, 21J0172JZX, 21J0176JZX, 21J0177JZX, 21J1088JZX, 21J1410JZX, 21J1411JZX, 21J1417JZX, 21J1418JZX, 21L0549JZX, 21L0550JZX, 21L0551JZX, 21L0552JZX, 21L0553JZX, 21L0756JZX, 21L0777JZX, 21L0778JZX, 21L0779JZX, 21L0796JZX, 21L0797JZX, 21L0801JZX, 21L0802JZX, 21L0803JZX, 21L0804JZX, 21L0805JZX, 21L0806JZX, 21L0807JZX, 21L0808JZX, 21L0809JZX, 21L0810JZX, 21L0811JZX, 21L0812JZX, 21L0813JZX, 21L0814JZX, 21L0815JZX, 21L0816JZX, 21L0817JZX, 21L0818JZX, 21L0819JZX 22A0665JZX, 22A0666JZX, 22A0670JZX, 22A0671JZX, 22A0672JZX, 22A0673JZX, 22A0674JZX, 22A0771JZX, 22A0772JZX, 22A0900JZX, 22A0901JZX, 22A0902JZX, 22A0903JZX, 22A0904JZX, 22A0905JZX, 22A0906JZX, 22A0907JZX, 22A0908JZX, 22A0909JZX, 22A0910JZX, 22A0911JZX, 22A0912JZX, 22A0913JZX, 22A0914JZX, 22A0915JZX, 22A0916JZX, 22B0277JZX, 22B0280JZX, 22B0288JZX, 22B0289JZX, 22B0290JZX, 22B0291JZX, 22B0334JZX, 22B0335JZX, 22B0336JZX, 22B0337JZX, 22C0758JZX, 22C0759JZX, 22D0936JZX, 22D0937JZX, 22D0938JZX, 22D0939JZX, 22D0940JZX, 22D0941JZX, 22D0942JZX, 22D0943JZX, 22D0944JZX, 22D0945JZX, 22D0946JZX, 22D0947JZX, 22D0948JZX, 22D0951JZX, 22D0952JZX, 22D0953JZX, 22D0954JZX, 22D0955JZX, 22D0956JZX, 22D0957JZX, 22D0958JZX, 22D0960JZX, 22D0961JZX, 22D0962JZX, 22D0963JZX, 22D0964JZX, 22D0965JZX, 22D0966JZX, 22D0967JZX, 22D0968JZX, 22D0969JZX, 22D0970JZX, 22D0971JZX, 22D0972JZX, 22G0403JZX, 22G0404JZX, 22G0405JZX, 22G0406JZX, 22G0407JZX, 22G0408JZX, 22G0414JZX, 22G0420JZX, 22H0872JZX, 22H0873JZX, 22H0874JZX, 22H0875JZX, 22H0877JZX, 22H0881JZX, 22H0886JZX, 22H0887JZX, 22J0084JZX, 22J0085JZX, 22J0086JZX, 22J0093JZX, 22J0094JZX, 22J0095JZX, 22J0096JZX, 22J0097JZX, 22J0098JZX, 22J0099JZX, 22J0100JZX, 22J0101JZX, 22J0102JZX, 22J0103JZX, 22J0104JZX, 22J0187JZX, 22J0189JZX, 22J0190JZX, 22J0191JZX, 22J0192JZX, 22J0193JZX, 22J0194JZX, 22J0196JZX, 22J0197JZX, 22J0198JZX, 22J0206JZX, 22K0244JZX, 22K1921JZX, 22K1922JZX, 22K1983JZX;  6CN75R/10884521205437/202110171X, 202110231X, 202110310X, 202110387X, 202111268X, 202203160X, 202203304X, 202203305X, 202203306X, 202203406X, 202204167X, 202206076X, 202206077X, 202206078X, 202207117X, 202207266X, 202207267X, 202207268X, 202208201X, 202208202X, 202209220X, 202210429X, 21G0479JZX, 21G0480JZX, 21G0481JZX, 21G0482JZX, 21L0522JZX, 21L0523JZX, 21L0524JZX, 21L0526JZX;  6UN75H/20884521176253/21C0420JZX, 21C0421JZX, 21C0422JZX, 21C0423JZX, 21C0424JZX, 21C0425JZX, 21C0426JZX, 21C0427JZX, 21C0428JZX, 21C0429JZX, 21C0430JZX, 21E1758JZX, 21E1759JZX, 21E1760JZX, 21E1761JZX, 21E1762JZX, 21E1763JZX, 21E1764JZX, 21E1765JZX, 21E1766JZX, 21E1767JZX, 21F0225JZX, 21G1158JZX, 21G1160JZX, 21G1161JZX, 21G1162JZX, 21G1163JZX, 21H0749JZX, 21H1009JZX, 21I0022JZX, 22B1035JZX, 22B1036JZX, 22B1039JZX, 22B1040JZX, 22B1041JZX, 22B1042JZX, 22B1043JZX, 22B1044JZX, 22B1045JZX, 22B1046JZX, 22B1047JZX, 22B1048JZX, 22B1049JZX, 22B1052JZX, 22B1053JZX, 22B1054JZX, 22C1511JZX, 22C1512JZX, 22C1513JZX, 22C1514JZX, 22C1515JZX, 22C1516JZX, 22C1518JZX, 22C1519JZX, 22D0792JZX, 22D0793JZX, 22D0794JZX, 22D0795JZX, 22D0796JZX, 22D0902JZX, 22D0903JZX, 22D0904JZX, 22D0905JZX, 22D0906JZX, 22D0907JZX, 22D0908JZX, 22D0913JZX, 22D0914JZX, 22D0915JZX, 22D0916JZX, 22D0919JZX, 22D0920JZX, 22D0921JZX, 22D0922JZX, 22E1002JZX, 22E1003JZX, 22E1004JZX, 22E1005JZX, 22E1008JZX, 22E1009JZX, 22E1010JZX, 22E1012JZX, 22E1013JZX, 22E1014JZX, 22E1015JZX, 22E1016JZX, 22E1017JZX, 22K0254JZX, 22K0255JZX, 22K0256JZX, 22K0257JZX, 22K0258JZX, 22K0259JZX, 22K0260JZX, 22K0261JZX, 22K0262JZX, 22K0263JZX, 22K0264JZX, 22K0265JZX, 22K0267JZX, 22K0268JZX, 22K0269JZX, 22K0270JZX, 22K0271JZX, 22K0272JZX, 22K0273JZX, 22K0274JZX, 22K0275JZX;  6UN75R/10884521205505/202107305X, 202107306X, 202108126X, 202108178X, 202108179X, 202109214X, 202109215X, 202109340X, 202111221X, 202111222X, 202111266X, 202201019X, 21G0487JZX, 21H0958JZX, 22B0728JZX, 22C1156JZX, 22C1157JZX, 22C1158JZX, 22C1159JZX, 22C1160JZX, 22E1001JZX, 22H0064JZX, 22H0065JZX, 22H0067JZX, 22H0068JZX, 22H0069JZX, 22H0072JZX, 22H0073JZX, 22H0075JZX, 22H0076JZX;  7CN80A/10884521172487/21C0355JZX, 22D0975JZX, 22D0976JZX, 22E0964JZX;  7CN80H/20884521176338/21C0381JZX, 21C0382JZX, 21C0383JZX, 21C0384JZX, 21D0442JZX, 21D0443JZX, 21E1698JZX, 21G0454JZX, 21I0402JZX, 21K0651JZX, 21K0652JZX, 21K0653JZX, 21K0654JZX, 21K0655JZX;  7CN80R/10884521205444/202104382X, 202104383X, 202105228X, 202105284X, 202106225X, 202203162X, 202203309X, 202204065X, 202206207X, 202206208X, 202206209X, 202206297X, 21G0791JZX;  7UN80A/20884521175737/20J0050JZX, 21C0356JZX, 21E1744JZX, 22C0313JZX, 22C0314JZX;  7UN80H/20884521176260/21C0431JZX, 21E1768JZX, 22C1527JZX, 22C1528JZX;  7UN80R/10884521205512/202203307X, 21G0774JZX;  8CN85A/10884521172494/21C0434JZX, 21C0435JZX, 21C0436JZX, 21I0287JZX, 21I0366JZX, 22A0136JZX, 22E1151JZX, 22E1152JZX, 22E1156JZX, 22E1157JZX; 8CN85H/20884521176345/21C0386JZX, 21C0387JZX, 21C0388JZX, 21C0389JZX, 21C0390JZX, 21C0391JZX, 21C0392JZX, 21C0393JZX, 21C0394JZX, 21C0395JZX, 21C0396JZX, 21C0397JZX, 21C0398JZX, 21C0399JZX, 21C0400JZX, 21C0401JZX, 21D0444JZX, 21D0445JZX, 21D0446JZX, 21D0447JZX, 21D0448JZX, 21D0449JZX, 21D0450JZX, 21D0451JZX, 21D0452JZX, 21D0453JZX, 21D0454JZX, 21D0455JZX, 21D0456JZX, 21D0457JZX, 21D0460JZX, 21E0623JZX, 21E0624JZX, 21E0625JZX, 21E0626JZX, 21E0627JZX, 21E0628JZX, 21E0629JZX, 21E0630JZX, 21E0631JZX, 21E1094JZX, 21E1095JZX, 21E1142JZX, 21E1143JZX, 21E1146JZX, 21E1147JZX, 21E1550JZX, 21E1551JZX, 21E1552JZX, 21E1711JZX, 21E1714JZX, 21E1715JZX, 21E1716JZX, 21E1717JZX, 21E1718JZX, 21E1719JZX, 21E1720JZX, 21E1721JZX, 21E1722JZX, 21E1723JZX, 21E1724JZX, 21E1725JZX, 21E1726JZX, 21E1727JZX, 21E1728JZX, 21E1729JZX, 21E1730JZX, 21E1731JZX, 21E1732JZX, 21E1733JZX, 21E1734JZX, 21E1735JZX, 21E1736JZX, 21E1737JZX, 21E1738JZX, 21F0524JZX, 21G0287JZX, 21G0288JZX, 21G0289JZX, 21G0290JZX, 21G0291JZX, 21G1149JZX, 21G1150JZX, 21H0796JZX, 21H0797JZX, 21I0330JZX, 21I0331JZX, 21I0332JZX, 21I0333JZX, 21I0334JZX, 21I0367JZX, 21I0368JZX, 21J0186JZX, 21J0187JZX, 21J0188JZX, 21J0189JZX, 21J0190JZX, 21J0191JZX, 21J0193JZX, 21L0333JZX, 22A0694JZX, 22A0695JZX, 22A0779JZX, 22A0780JZX, 22A0781JZX, 22A0782JZX, 22A0783JZX, 22A0784JZX, 22A0785JZX, 22A0786JZX, 22A0787JZX, 22A0788JZX, 22A0820JZX, 22A0821JZX, 22A0822JZX, 22A0823JZX, 22A0824JZX, 22A0825JZX, 22A0826JZX, 22A0827JZX, 22A0828JZX, 22A0829JZX, 22A0830JZX, 22A0831JZX, 22A0832JZX, 22A0833JZX, 22A0835JZX, 22A0836JZX, 22C0795JZX, 22C0797JZX, 22C0798JZX, 22C0799JZX ,22C0800JZX ,22C0802JZX 22C0813JZX, 22C0814JZX, 22C0815JZX, 22C0819JZX, 22C0820JZX, 22E1231JZX, 22E1232JZX, 22E1233JZX, 22E1234JZX, 22E1235JZX, 22E1236JZX, 22E1237JZX, 22E1238JZX, 22E1239JZX, 22E1240JZX, 22E1243JZX, 22E1244JZX, 22E1245JZX, 22E1246JZX, 22E1247JZX, 22E1248JZX, 22E1249JZX, 22E1260JZX, 22E1261JZX, 22E1262JZX, 22E1263JZX, 22E1264JZX, 22E1265JZX, 22E1266JZX, 22E1267JZX, 22F0476JZX, 22F0477JZX, 22F0478JZX, 22F0479JZX, 22F0480JZX, 22F0481JZX, 22F0482JZX, 22F0483JZX, 22F0484JZX, 22F0485JZX, 22F0486JZX, 22F0487JZX, 22F0488JZX, 22F0489JZX, 22F0490JZX, 22F0491JZX, 22F0492JZX, 22F0493JZX, 22F0494JZX, 22F0495JZX, 22F0496JZX, 22F0497JZX, 22F0498JZX, 22F0499JZX, 22F0500JZX, 22F0501JZX, 22F0502JZX, 22F0503JZX, 22F0504JZX, 22F0505JZX, 22F0506JZX, 22F0862JZX, 22F0863JZX, 22F0864JZX, 22F0897JZX, 22F0898JZX, 22F0899JZX, 22F0900JZX, 22I0530JZX, 22I0531JZX, 22I0532JZX, 22I0533JZX, 22I0534JZX, 22J0120JZX, 22J0121JZX, 22J0122JZX, 22J0123JZX, 22J0124JZX, 22J0125JZX, 22J0126JZX, 22J0127JZX, 22J0128JZX, 22J0129JZX, 22J0130JZX, 22J0131JZX, 22J0132JZX, 22J1084JZX, 22J1085JZX, 22J1096JZX, 22J1097JZX, 22J1098JZX, 22J1099JZX, 22J1100JZX, 22J1101JZX, 22J1102JZX, 22J1103JZX, 22J1104JZX, 22J1105JZX, 22J1107JZX, 22J1108JZX, 22J1109JZX, 22J1115JZX;  8CN85R/10884521205451/202106382X, 202107194X, 202107195X, 202107196X, 202109037X, 202109124X, 202109168X, 202110189X, 202111087X, 202111106X, 202111115X, 202201302X, 202202117X, 202202118X, 202202120X, 202202323X, 202202438X, 202204062X, 21H0762JZX, 21H0763JZX, 21H0764JZX, 21H0795JZX, 21H0951JZX, 21H0952JZX, 21J0382JZX, 21J0383JZX, 22A0732JZX, 22F0889JZX, 22H0040JZX;  8UN85A/20884521175744/22C1488JZX;  8UN85H/20884521176277/21C0408JZX, 21C0409JZX, 21C0410JZX, 21E0653JZX, 21E0654JZX, 21E1745JZX, 21E1746JZX, 21E1747JZX, 21E1748JZX, 21E1749JZX, 21E1750JZX, 21E1751JZX, 21E1752JZX, 21E1753JZX, 21F0523JZX, 21H0479JZX, 21L0296JZX, 21L0297JZX, 21L0298JZX, 21L0299JZX, 21L0300JZX, 21L0301JZX, 21L0302JZX, 21L0303JZX, 21L0304JZX, 21L0305JZX, 21L0380JZX, 22B1059JZX, 22B1060JZX, 22C1484JZX, 22C1485JZX;  8UN85R/10884521205529/202105199X, 202105200X, 202105201X, 202105383X, 202105384X, 202105385X, 202106264X, 202106265X, 202106313X, 202106314X, 202106315X, 202106316X, 202107063X, 202107064X, 202107065X, 202107113X, 202107114X, 202107115X, 202107116X, 202107202X, 202108121X, 202108187X, 202108188X, 202108230X, 202202326X, 202203066X, 202203409X, 202208021X, 202209336X, 21G0922JZX, 22C1430JZX, 22C1432JZX;  9CN90H/20884521176352/21C0411JZX, 21C0412JZX, 21D0464JZX, 21D0465JZX, 21D0601JZX, 21I0555JZX, 21I0556JZX, 21K0262JZX, 21K0263JZX;  9CN90R/10884521205468/202105281X, 202110114X, 202202327X, 202204166X, 202205514X;  9UN90H/20884521176284/21E0657JZX, 21E0658JZX;  9UN90R/10884521205536/202203308X, 21F0328JZX. 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-1357-2023&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-1357-2023&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-1357-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1357-2023 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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)",
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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT, WY, DC, UT, NV, NH, RI, ID, NM, ME and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bolivia, Plurinational State Of Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Malta, Martinique, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic Of Tanzania, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, Viet Nam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}