3M Steri-Vac Gas Sterilizer/Aerator — Class II medical device recall Z-1563-2016
Terminated recall by 3M Company - Health Care Business, reported 2016-05-04, distributed in AL, CO, CT, FL, GA, IN, NC, NJ…. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the
| Recall number | Z-1563-2016 |
|---|---|
| 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 | 2016-01-22 |
| Classified | 2016-04-24 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-08-25 |
| Distributed | AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI |
| Countries outside the US | AE, AR, CA, CH, CL, CN, DE, ID, IN, JP, KR, MX, PE, PH, SV, TH, TR, TT, VN, ZA |
| Quantity | 74 valves |
| Reason classes | labeling |
| Serial numbers | 351303, 351399, 450144, 450147, 722612, 722683, 820352, 820360 |
| Model numbers | 5XL, 8XL |
Product
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Reason for recall
3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
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-1563-2016. 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.