Model 731 EMV+ Uni-Vent — Class III medical device recall Z-2152-2012
Terminated recall by Impact Instrumentation, Inc., reported 2012-08-15, distributed in IL. Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed
| Recall number | Z-2152-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impact Instrumentation, Inc., West Caldwell, NJ, United States |
| Recall initiated | 2012-03-19 |
| Classified | 2012-08-07 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2012-08-15 |
| Distributed | IL |
| Serial numbers | VCDB120297, VCDB120299, VCDB120300, VCDB120303, VCDB120307, VCDB120310, VCDB120312, VCDB120313, VCDB120315, VCDB120316 |
| Model numbers | 731 |
Product
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
Reason for recall
Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
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-2152-2012. 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.