AirLife Adult Manual Resuscitator — Class I medical device recall Z-1061-2024
Ongoing recall by Vyaire Medical, reported 2024-03-06, distributed nationwide. Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing
| Recall number | Z-1061-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2024-01-10 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CH, FR, GB, MX, NL, SA, SE, ZA |
| Quantity | 3,683,407 units |
| Reason classes | microbial contamination, specification failure |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 10190752114159, 50190752114157 |
| Model numbers | 2K8005 |
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Reason for recall
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
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-1061-2024. 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.