COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7 — Class II medical device recall Z-1318-2023
Ongoing recall by Covidien, reported 2023-04-05, distributed in AK, AZ, CA, FL, GA, IA, IL, IN…. Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
| Recall number | Z-1318-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Boulder, CO, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-03-31 |
| Reported by FDA | 2023-04-05 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 12,310 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 60884522000241 |
| Lot numbers | 22G0343JZX, 22G0344JZX |
| Model numbers | 7.0, 86051 |
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 for recall
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
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-1318-2023. 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.