Critical Care Decontamination System — Class II medical device recall Z-0309-2021
Terminated recall by Battelle Memorial Institute, reported 2020-11-04, distributed nationwide. Masks processed at one site were not maintained at levels of condensation during a portion of the decontaminat
| Recall number | Z-0309-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Battelle Memorial Institute, Columbus, OH, United States |
| Recall initiated | 2020-08-13 |
| Classified | 2020-10-29 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 898 |
Product
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.
Reason for recall
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0309-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.