FDA Device recall Z-1461-2024
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
- FDA Device
- Class III
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class III recall of HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) by O And M Halyard, citing product was mislabeled as a Surgical Cap at its dispenser level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-02-20 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | O And M Halyard |
| Distribution | US |
Product
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Reason
Product was mislabeled as a Surgical Cap at its dispenser level.
Identifiers
| code_info | Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 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-1461-2024%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.