CLASS I ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report
Shiley Adult Flexible Tracheostomy Tube recalled by Covidien
Covidien is recalling Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable, distributed nationwide in the US. The recall was initiated on 24 Mar 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1357-2023
- FDA event ID
- 91943
- Recalling firm
- Covidien, Boulder, CO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Mar 2023
- FDA classified
- 19 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 24 Mar 2023 | Recall initiated by company | |
| 19 Apr 2023 | Classified by FDA | +26 days |
| 26 Apr 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
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.
Which lots 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; 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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; 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Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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