FDA Device recall Z-2626-2023
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 by O And M Halyard, citing one respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2626-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-09 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | O And M Halyard |
| Distribution | FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI |
Product
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Reason
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Identifiers
| code_info | UDI-DI: 20680651468271; Lot Number AM2164811 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2626-2023%22
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