AirLife Resuscitation — Class I medical device recall Z-1557-2018
Terminated recall by Vyaire Medical, reported 2018-05-16, distributed nationwide. The mask component on various lots of the resuscitation devices have been identified as having the potential t
| Recall number | Z-1557-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Vernon Hills, IL, United States |
| Recall initiated | 2017-04-27 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PH |
| Quantity | 24 units |
| Lot numbers | 0001002929 |
| Model numbers | 2K8008C2 |
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Reason for recall
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
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-1557-2018. 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.