Ventlab Premium Small Adult Resuscitator — Class I medical device recall Z-0178-2013
Terminated recall by Ventlab Corporation, reported 2012-11-07, distributed nationwide. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
| Recall number | Z-0178-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventlab Corporation, Mocksville, NC, United States |
| Recall initiated | 2012-07-11 |
| Classified | 2012-11-01 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 14,602 for |
| Reason classes | packaging |
| Lot numbers | 102194 |
Product
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Reason for recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
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-0178-2013. 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.