Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff — Class I medical device recall Z-1357-2023

Ongoing recall by Covidien, reported 2023-04-26, distributed nationwide. A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connecto

Recall number	`Z-1357-2023`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Covidien, Boulder, CO, United States
Recall initiated	2023-03-24
Classified	2023-04-19
Reported by FDA	2023-04-26
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GR, HK, HU, ID, IE, IL, IS, IT, JO, KW, LB, LT, LU, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TR, TT, TW, VN, ZA
Quantity	599,187
UPC / GTIN / UDI-DI	`10884521172371`, `10884521172456`, `10884521172463`, `10884521172470`, `10884521172487`, `10884521172494`, `10884521205024`, `10884521205420`, `10884521205437`, `10884521205444`, `10884521205451`, `10884521205468`, `10884521205475`, `10884521205482`, `10884521205499`, `10884521205505`, `10884521205512`, `10884521205529`, `10884521205536`, `10884521205543`, `20884521175690`, `20884521175706`, `20884521175713`, `20884521175737`, `20884521175744` and 13 more
Lot numbers	`202104383X`, `202105200X`, `202105201X`, `202105228X`, `202105284X`, `202105308X`, `202105310X`, `202105383X`, `202105384X`, `202105385X`, `202106148X`, `202106225X`, `202106264X`, `202106265X`, `202106267X`, `202106268X`, `202106313X`, `202106314X`, `202106315X`, `202106316X`, `202107063X`, `202107064X`, `202107065X`, `202107113X`, `202107114X`, `202107115X`, `202107116X`, `202107194X`, `202107195X`, `202107196X`, `202107202X`, `202107294X`, `202107295X`, `202107296X`, `202107298X`, `202107299X`, `202107300X`, `202107306X`, `202108121X`, `202108122X` and 460 more

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1357-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.