FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask… — Class II medical device recall Z-2626-2023
Ongoing recall by O&M HALYARD, INC., reported 2023-09-27, distributed in FL, GA, IA, IL, MO, MS, NE, OK…. One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection
| Recall number | Z-2626-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | O&M HALYARD, INC., Mechanicsville, VA, United States |
| Recall initiated | 2023-08-09 |
| Classified | 2023-09-21 |
| Reported by FDA | 2023-09-27 |
| Distributed | FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI |
| Quantity | 41,790 masks |
| UPC / GTIN / UDI-DI | 20680651468271 |
| Lot numbers | AM2164811 |
Product
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Reason for recall
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
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-2626-2023. 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.