The Recall Desk
HighFDA (Devices)·Z-0022-2013·Announced 2012-10-17

3M Recalls Steri-Vac Gas Sterilizers Due to Electrical Grounding Defect

3M is recalling Steri-Vac 5XL and 8XL gas sterilizers because the electrical grounding mechanism did not meet safety standards.

What this means for you

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-harm product (electrical defect) where injury has not yet been reported, fitting the 'High' severity criteria for unreported injury risks.

Plain-English summary

3M Company - Health Care Business is recalling 707 units of Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. The recall involves specific serial numbers for 1-door and 2-door configurations of both models.

The recall was initiated because 3M determined that the electrical grounding mechanism did not meet all requirements of the applicable standard. Specifically, the insulated electrical wiring contained within the sealed door should have a stronger connection to the protective electrical grounding mechanism.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Consumers and healthcare facilities should check their equipment serial numbers against the recall list and contact 3M for further instructions.

The recalled product

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.
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Sterilization Equipment
Hazard

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 (5)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

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