Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3M Attest Auto-reader. Model numbers 390 Recalled by 3M Company - Health Care Business Due to Labeling on units shipped prior to May 16th,...
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 Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Quantity: 5343 (2621 USA, 2722 OUS)
Why Was This Recalled?
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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