Covidien: 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

Recall number

Z-1357-2023

Recalling firm

Covidien

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

Status

Open, Classified

Initiated

2023-03-24

Posted

2023-04-19

Terminated

not on file

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.

Root cause

Component change control

Action

On 3/24/23, recall notices were mailed to risk managers and directors of respiratory care. Tracheostomy Tubes that do not securely attach or stay attached to caps or accessories should not be used. 1) All affected unused product should be quarantined and returned to the recalling firm. 2) Complete and then return the customer confirmation form to rs.gmbfcamitg@medtronic.com 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. 4) If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. Customers with questions can contact Quality Assurance at 800-255-6774, option 4.

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.

Lot, serial or model 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; 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510(k) numbers

["K142296","K150844"]

PMA numbers

not on file

Product code

JOH

Firm FEI

2936999

Firm city

Boulder

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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