AirLife Resuscitation Device — Class I medical device recall Z-2552-2018
Terminated recall by Vyaire Medical, reported 2018-08-15, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of t
| Recall number | Z-2552-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-07-07 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PR, SD, TX, VA, WA |
| Quantity | 15,714 units |
| Lot numbers | 0001207345, 0001207346, 0001207347, 0001207349, 0001207350, 0001207351, 0001207352, 0001207353, 0001207354, 0001209833, 0001209835, 0001209836, 0001209841, 0001209842, 0001209843, 0001209844, 0001209847, 0001210191, 0001210192, 0004003362, 0004003363, 001209834 |
| Model numbers | 2K8001, 2K8004, 2K8004C2, 2K8005, 2K8017, 2K8035C2, 2K8035M, 2K8036 |
Product
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
Reason for recall
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
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-2552-2018. 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.