FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
- Recall number
- Z-1563-2016
- Recalling firm
- 3M Company - Health Care Business
- Product
- 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
- Status
- Terminated
- Initiated
- 2016-01-22
- Posted
- not on file
- Terminated
- 2016-08-25
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.
- Quantity
- 74 valves
- Distribution
- AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.
- Lot, serial or model codes
- Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
- 510(k) numbers
- K902036, K941748
- PMA numbers
- not on file
- Product code
- FLF
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28