FDA Device recall Z-1563-2016
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL by 3m Health Care Business, citing 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 va….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1563-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-22 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 3m Health Care Business |
| Distribution | AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI |
Product
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Reason
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.
Identifiers
| code_info | Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All 3m Health Care Business recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1563-2016%22
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