Recall Register

Food, drugs, devices › Firms

O&M HALYARD INC

FDA recalling firm · 7 enforcement events · 8 product records · 2021–2026 · VA, GA

O&M HALYARD INC has 7 FDA enforcement events on this register (8 product records) between 2021 and 2026: 7 device; the busiest year was 2024 with 3.

0% of its events are Class I; the most common class is Class II (6). 7 events are listed as ongoing; the recalling firm's address is in VA and GA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
13 Apr 2026Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)DeviceClass II1Ongoing
17 Jul 2025Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029DeviceClass II1Ongoing
26 Nov 2024Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/ADeviceClass II1Ongoing
8 Nov 2024O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117DeviceClass II2Ongoing
20 Feb 2024HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)DeviceClass III1Ongoing
9 Aug 2023FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827DeviceClass II1Ongoing
27 Sep 2021HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XLDeviceClass II1Ongoing

By type and class

Device7
Class II6
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

21
22
23
24
25
26
Enforcement events for O&M HALYARD INC by year initiated.

Questions and answers

How many FDA recalls has O&M HALYARD INC had?

7 enforcement events (8 product records) on this register, 2021–2026: 7 device.

Are any O&M HALYARD INC recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are O&M HALYARD INC recalls?

6 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.