3M" Steri-Vac" Gas Sterilizer/Aerators — Class II medical device recall Z-1318-2014
Terminated recall by 3M Company - Health Care Business, reported 2014-04-09, distributed nationwide. Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installatio
| Recall number | Z-1318-2014 |
|---|---|
| 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 | 2014-03-17 |
| Classified | 2014-04-02 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2015-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BG, CA, CH, CL, CN, CO, DE, EC, ES, GT, ID, IL, IN, JP, KR, LB, MX, MY, NZ, PE, PL, RO, RU, SV, TH, TR, TW, VE |
| Reason classes | chemical contamination |
| Model numbers | 4XL, 5XL, 8XL |
Product
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 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
Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20
Machine access
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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.