FDA Device recall Z-1061-2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 by Vyaire Medical, citing 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 ve….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1061-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-01-10 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Vyaire Medical |
| Distribution | US |
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Reason
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.
Identifiers
| code_info | UDI/DI Case: 50190752114157, Each: 10190752114159; All manufacturing dates of 2017 and prior, and any products without a manufacturing date. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1061-2024%22
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