Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3M" Steri-Vac" Gas Sterilizer/Aerators Recalled by 3M Company - Health Care Business Due to Recently, 3M received a single report of a...

Date: March 17, 2014
Company: 3M Company - Health Care Business
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 3M Company - Health Care Business directly.

Affected Products

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.

Quantity: 73 US, 346 OUS

Why Was This Recalled?

Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About 3M Company - Health Care Business

3M Company - Health Care Business has 40 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report