Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 17, 2012
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electri…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
3M Company - Health Care Business recalled 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Ae… - a moderate-severity action.
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Ae… was recalled by 3M Company - Health Care Business in October 17, 2012. Reason: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator di…. Check the official notice for the remedy. Verify recall #Z-0022-2013 with the FDA Devices before acting.
The recall
3M Company - Health Care Business issued this moderate-severity FDA Devices recall-3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator di….
- Moderate
- severity level
- 707 units
- affected scope
- Class II
- classification
- October 17, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0022-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0022-2013) was formally reported on October 17, 2012, with the manufacturer initiating the action on September 13, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. 3M Company - Health Care Business is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 707 units (61 US, 646 OUS).
The documented reason for this recall is: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and conta… Distribution data in the federal record shows the product reached: Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa R…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
707 units (61 US, 646 OUS)
Related Recalls
6
3 from same agency
Product description
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Reason for recall
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0022-2013 |
| Date reported | October 17, 2012 |
| Date initiated | September 13, 2012 |
| Recalling firm | 3M Company - Health Care Business |
| Firm location | Saint Paul, MN |
| Affected scope | 707 units (61 US, 646 OUS) |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, German… |
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-0022-2013) 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? ▼
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.. Recalled by 3M Company - Health Care Business. Units affected: 707 units (61 US, 646 OUS).
Why was this product recalled? ▼
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0022-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0022-2013) 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 October 17, 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.