FDA Device recall Z-1390-2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
- FDA Device
- Class I
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class I recall of Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R by Covidien, citing 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, unspec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-26 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Covidien |
| Distribution | n/a |
Product
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Reason
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.
Identifiers
| code_info | UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.