3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL — Class II medical device recall Z-0022-2013
Terminated recall by 3M Company - Health Care Business, reported 2012-10-17, distributed nationwide. 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did
| Recall number | Z-0022-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2012-09-13 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BB, CL, CN, CO, CR, DE, EC, ID, IN, JP, KR, KW, LB, MA, MX, MY, PE, PH, PK, PL, PY, RU, TH, TT, TW, VE, VN, ZA |
| Model numbers | 1-DOOR, 2-DOOR, 5XL, 8XL |
Product
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.
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-0022-2013. 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.