Z-2626-2023Class II

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small...

Name: Z-2626-2023 FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small...
Creator: O&m Halyard, Inc.
Published: 2023-08-09
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2023-08-09 / Open, Classified

FDA source

O&M HALYARD, INC. began a recall of FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 on 2023-08-09. FDA classified it as Class II and gives the reason as "One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2626-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-09
Posted: 2023-09-21
Recalling firm: O&M Halyard, Inc.
Product: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Product code: MSH Respirator, Surgical
Reason for recall: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 41790 masks
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 codes and lots: UDI-DI: 20680651468271; Lot Number AM2164811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2626-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2626-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-21

Product code MSH

K974068Class IIPfr95 Particulate Filter Respirator and Surgical Mask Regular Size, Pfr95 Particulate Filter Respirator and SurgicalTecnol Medical Products, Inc. / cleared 1997-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)