Stop using now Medical device recall · FDA · Published August 13, 2020

Battelle Recalls CCDS Compatible N95 Respirators Due to Decontamination Failure

Battelle Memorial Institute recalls 898 Critical Care Decontamination System compatible N95 respirators distributed from Providence, RI between July and August 2020 due to decontamination process errors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0309-2021Medical device Battelle Memorial Institute ›

Stop using this now

Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

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Contact the company

Recalling firmBattelle Memorial Institute505 King Ave · Columbus, OH 43201-2696

✎ GovInfoNow plain-language explainer

Battelle Memorial Institute is recalling 898 Critical Care Decontamination System (CCDS) compatible N95 respirators because they may not have been properly decontaminated. The masks processed at one site failed to maintain the necessary levels of condensation during part of the decontamination cycle, potentially leaving harmful pathogens on the equipment. These units were distributed nationwide from Providence, Rhode Island between July 1 and August 12, 2020. Read more at govinfonow.com/recall/64487-battelle-critical-care-decontamination-n95-respirators-risk-of-inadequate-decontamination.

Source Summary by GovInfoNow · govinfonow.com/recall/64487-battelle-critical-care-decontamination-n95-respirators-risk-of-inadequate-decontamination · Updated October 13, 2026 · FDA enforcement record: FDA #Z-0309-2021

Cite this page

“Battelle Recalls CCDS Compatible N95 Respirators Due to Decontamination Failure.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/64487-battelle-critical-care-decontamination-n95-respirators-risk-of-inadequate-decontamination. Based on FDA recall #Z-0309-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2021%22&limit=1).

The Food and Drug Administration announced on Aug. 13, 2020, that Battelle Memorial Institute voluntarily recalled Critical Care Decontamination System (CCDS) Compatible N95 respirators because masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

How to tell if you have it

Brand: Battelle Memorial Institute
Product: CCDS Compatible N95 Respirators
Distribution: US Nationwide including CT, MA, RI
Dates distributed: 07/01/2020 to 08/12/2020
Quantity: 898 units

The hazard

According to the FDA, masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

Context

GovInfoNow's records show other recent recalls of similar products include Getinge Thoracic Catheter Recall: Bacterial Endotoxin Testing Issue (2026-08-07).

How to tell if you have this one

Look for N95 respirators that are labeled as compatible with the Critical Care Decontamination System (CCDS). Check if they were distributed from Providence, RI between July 1, 2020, and August 12, 2020. The total quantity affected is 898 units.

Brand
Battelle Memorial Institute
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using the Respirators
Do not use these respirators for decontamination or protection due to the risk of pathogen exposure from incomplete processing.
Contact Battelle Memorial Institute
Reach out to the manufacturer for further instructions regarding the recall remedy, as specific return or disposal steps are not detailed in this record.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution including in the states of CT, MA, RI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Massachusetts, Rhode Island.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

Aug 13, 2020Firm started the recall
Oct 29, 2020FDA classified it Class II
Nov 4, 2020Published in FDA’s Enforcement Report
Feb 3, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Battelle Memorial Institute recalls

Link to this recall

<a href="https://govinfonow.com/recall/64487-battelle-critical-care-decontamination-n95-respirators-risk-of-inadequate-decontamination">Battelle Recalls CCDS Compatible N95 Respirators Due to Decontamination Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0309-2021 (August 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0309-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.