3M Steri-Vac Gas Sterilizers Recalled for Ethylene Oxide Exposure Risk
3M is recalling Steri-Vac Gas Sterilizers due to a rare failure that could cause ethylene oxide exposure. The issue affects specific models manufactured in late 2006 and 2007.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of exposure to Ethylene Oxide, a hazardous chemical, but only a single potential exposure report is cited without confirmed injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
3M Company - Health Care Business is recalling specific models of the 3M Steri-Vac Gas Sterilizer/Aerator, including models 4XL, 5XL, and 8XL. The recall is due to a single report of potential exposure to Ethylene Oxide (EO) at a hospital installation. The cause was traced to a rare failure of the EO cartridge puncture assembly, a component that was in production from November 10, 2006, through December 14, 2007.
The affected units were distributed worldwide, including in the United States and numerous international markets. The recall covers 73 units in the US and 346 units outside the US. Specific serial number ranges for the 5XL, 8XL, and 4XL models are listed in the official recall documentation.
Healthcare facilities and consumers should check their equipment serial numbers against the provided list. If a unit is affected, it should be removed from service. 3M is the recalling firm responsible for managing this safety action.
The recalled product
- 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.
- Manufacturer
- 3M Company - Health Care Business
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 522205
- 522502
- 522287
- 522655.
Distribution
Related recalls
Same manufacturer · 3M Company - Health Care Business
See all →- High3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
FDA (Devices) · 2025-01-01
- High3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination
FDA (Devices) · 2024-10-16
- Moderate3M Durapore Surgical Tape incorrectly labeled with extended shelf life
FDA (Devices) · 2024-05-01
- Moderate3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects
FDA (Devices) · 2024-04-10
- High3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
FDA (Devices) · 2024-02-28
Same hazard · chemical exposure
See all →- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Similar recalls
- High3M Recalls Steri-Vac Gas Sterilizers Due to Electrical Grounding Defect
FDA (Devices) · 2012-10-17
- High3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error
FDA (Devices) · 2016-05-04
- HighSteris Eagle 3000 Sterilizer Recall Due to Incorrect Safety Valve
FDA (Devices) · 2019-12-11
- HighQUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
FDA (Devices) · 2023-06-07
- Moderate3M and Comply Sterilization Indicators Recalled for Temperature Excursions
FDA (Devices) · 2022-10-05
- ModerateAdvanced Sterilization Products Recalls Sterrad 100NX Sterilizers Due to Odor Reports
FDA (Devices) · 2013-11-20