Shiley Adult Flexible Tracheostomy Tube with TaperGuard recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product…

Recalling firm

Covidien

Quantity

599,187

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.

Recall date

April 26, 2023

Classification

Class I

Status

Ongoing

Agency

FDA (device)