Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 15, 2012
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Impact Instrumentation, Inc. recalled Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell N… - a low-severity action.
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell N… was recalled by Impact Instrumentation, Inc. in August 15, 2012. Reason: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was complete…. Check the official notice for the remedy. Verify recall #Z-2152-2012 with the FDA Devices before acting.
The recall
Impact Instrumentation, Inc. issued this low-severity FDA Devices recall-Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was complete….
- Low
- severity level
- Class III
- classification
- August 15, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2152-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2152-2012) was formally reported on August 15, 2012, with the manufacturer initiating the action on March 19, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Impact Instrumentation, Inc. is listed as the recalling firm, operating out of West Caldwell, NJ. Federal records list the affected scope as Ten Units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution to the state of Illinois.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Ten Units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2152-2012 |
| Date reported | August 15, 2012 |
| Date initiated | March 19, 2012 |
| Recalling firm | Impact Instrumentation, Inc. |
| Firm location | West Caldwell, NJ |
| Affected scope | Ten Units |
| Distribution | US Distribution to the state of Illinois. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2152-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Impact Instrumentation, Inc.. Units affected: Ten Units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Low. Recall number: Z-2152-2012.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the state of Illinois..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2152-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 15, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.