--- title: "Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: D... — FDA record Z-1357-2023 | Is It on Recall" description: "A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15m" url: https://isitonrecall.com/recall/fda-device-z-1357-2023-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-and-cuffless-disposable-inner-cannula-o/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inne... — FDA record Z-1357-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Mar 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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. - **Classification**: Class I - **Recalling firm**: Covidien - **Quantity**: 599,187 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1357-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1357-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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, 21J0... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1357-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution 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. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 26, 2023 - **Recall initiation date**: Mar 24, 2023 - **Center classification date**: Apr 19, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1357-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Covidien records](https://isitonrecall.com/brand/covidien/)