FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: 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.
- Recall number
- Z-0022-2013
- Recalling firm
- 3M Company - Health Care Business
- 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.
- Status
- Terminated
- Initiated
- 2012-09-13
- Posted
- 2012-10-09
- Terminated
- 2013-01-29
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- 3m Healthcare Service Center sent a Urgent Medical Device Field Correction letter dated September 19. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3Ms goal is to service the affected units with minimal disruption to your facility. We apologize for any inconvenience this field correction may cause. Please be assured that 3M is committed to the highest level of safety and customer service and we are proud of our longstanding safety record for 3M" Steri-Vac" Gas Sterilizers. For Further Information If you have any questions, please contact the 3M Health Care Service Line at 1-800-688-5888 or your local 3M representative. .
- Quantity
- 707 units (61 US, 646 OUS)
- Distribution
- Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.
- Lot, serial or model codes
- Model 5XL 1-door, serial numbers from 721799 - 722166. Model 5XL 2-door, serial numbers from 820248 - 820285. Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105
- 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