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.
Other recalls by O And M Halyard
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
FDA Device · Class II · 2026-06-03 · O And M Halyard - Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
FDA Device · Class II · 2025-09-10 · O And M Halyard - Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Co…
FDA Device · Class II · 2025-01-29 · O And M Halyard - O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Device · Class II · 2025-01-01 · O And M Halyard - O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
FDA Device · Class II · 2025-01-01 · O And M Halyard
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2626-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.