Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable… — Class I medical device recall Z-1390-2025
Ongoing recall by Covidien, reported 2025-04-02. Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of
| Recall number | Z-1390-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Boulder, CO, United States |
| Recall initiated | 2025-02-26 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Countries outside the US | DE, ES, FR, IE, IT, LT, PT, SA, SI, SK, TW, ZA |
| Quantity | 780 |
| UPC / GTIN / UDI-DI | 08845212054401, 10884521205444, 20884521205441 |
| Lot numbers | 202405258X |
| Model numbers | 7CN80R |
| Expiration dates | 2029-06-01 |
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Reason for recall
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
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-1390-2025. 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.