Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Recalled by Battelle Memorial Institute Due to Masks processed at one site were not maintained...
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 Battelle Memorial Institute directly.
Affected Products
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
Quantity: 898
Why Was This Recalled?
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Battelle Memorial Institute
Battelle Memorial Institute has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report