Recall archive / 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. Source coverage and dates.

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

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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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.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

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