Recall Z-2261-2026 ยท JOH Tube Tracheostomy And Tube Cuff
Covidien LLC
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer
| Date | May 29, 2026 (initiated Apr 15, 2026) |
| Status | Open, Classified |
| Reason | Due to customer complaint regarding incorrect display box labeling. |
| Root cause | Process control |
| Action | On 04/15/2026, the firm sent via mail/email an "Urgent Medical Device Recall" Letter to customers informing them that due to a manufacturing process packaging error, correctly manufactured and labeled individual units of the Covidien Shiley" cuffed fenestrated adult tracheostomy tube with reusable inner cannula were inadvertently placed into incorrect display boxes. A customer report indicating that the product display box is incorrectly labeled as item code 6CFN, which corresponds to cuffless devices. The correct item code is 6FEN, and it appears correctly on all other labeling, including the |
| Quantity | 1,002 |
| Distribution | Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812302 | SHILEY FENESTRATED LOW PRESS. CUFFED Shiley, Inc., Sep 8, 1981 |