FLUIDSHIELD 3 N95 Particulate Filter Respirator and… recallZ-2626-2023 · O&M Halyard, Inc. · initiated Aug 9, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from O&M Halyard, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
FDA root cause category: Under Investigation by firm
What the company is doing
An "URGENT: PRODUCT FIELD ACTION" dated 8/9/23 was sent to customers. The letter described the product, the problem and actions to take. The customers were instructed to do the following: If you received the lot identified above, please review your inventory, and segregate and quarantine all affected product. All other codes and lots of this product are NOT impacted by this Field Action. Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 2. SEGREGATE AND QUARANTINE all product on-hand per the Affected Product table above. 3. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 4. COMMUNICATE this Field Action to staff to ensure awareness of it. 5. RETURN the completed Field Action Response Form and Certificate of Destruction Form to [email protected] as soon as possible even if you have no current product inventory. 6. Any adverse events associated with the use of the affected product should be reported to [email protected]. 7. If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, please email Anu Singh @ [email protected] using the Event # FA-2023-011 in the header of the response. This will ensure prompt response by the O&M Halyard, Inc. team.
Recall details
- Recall number
- Z-2626-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 9, 2023
- Posted by the FDA
- Sep 21, 2023
- Recalling firm
- O&M Halyard, Inc.
- Quantity
- 41790 masks
- Product code
- MSH
- FDA submissions
- K974068
- Distribution
- US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia
Product description
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Code information (models, lots, serial numbers)
UDI-DI: 20680651468271; Lot Number AM2164811
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 46827O&M Halyard, Inc. · Respirator, Surgical1 recall33 reports
Other devices under the same FDA submission
1 device cleared under K974068 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Halyard 76727O&M Halyard, Inc. · Respirator, surgical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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