2 — Class II medical device recall Z-0371-2023
Ongoing recall by Bunnell, Inc., reported 2022-12-14, distributed nationwide. Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, w
| Recall number | Z-0371-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bunnell, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2022-11-02 |
| Classified | 2022-12-02 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,606 assemblies |
| UPC / GTIN / UDI-DI | 00616120000082, 10616120000034, 10616120000089 |
| Lot numbers | 2.5, 22042320, 9025/10616120000034/22042320 |
| Model numbers | 9025, 938 |
Product
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
Reason for recall
Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
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-0371-2023. 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.