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.

Recall Insight

This FDA Devices action (record #Z-0309-2021) was formally reported on November 4, 2020, with the manufacturer initiating the action on August 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Battelle Memorial Institute is listed as the recalling firm, operating out of Columbus, OH. Federal records indicate 898 units are affected.

The documented reason for this recall is: Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of CT, MA, RI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.