FDA Device recall Z-1318-2023
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicate…
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicate… by Covidien, citing due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1318-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-10 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | AK, AZ, CA, FL, GA, IA, IL, IN, KS, MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, WV |
Product
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
Reason
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Identifiers
| code_info | Product Number: 86051 UDI-DI (GTIN) Code: 60884522000241 Lot Numbers: 22G0343JZX 22G0344JZX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1318-2023%22
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