Recall Register

O&M HALYARD INC: FDA recalls

FDA enforcement events from 2021 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name O&M HALYARD INC as the recalling firm in 7 events. The events have 8 product records. The recalls started from 2021 to 2026. All the events are device recalls. By FDA enforcement events, O&M HALYARD INC is number 506 of 1,628 firms that have a page. Events that O&M HALYARD INC started: 3 in 2024 and 1 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 85.7% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

7 events, newest first.

FDA enforcement events of O&M HALYARD INC
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

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

O&M HALYARD INC: events for each product type
TypeEvents
Device7
O&M HALYARD INC: events in each class
ClassEvents
Class II6
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
7

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of O&M HALYARD INC, by the year that the recall started. The largest year is 2024, with 3 events.

Official channels

Cite this page

Recall Register. O&M HALYARD INC: FDA recalls. https://recallregister.com/firm/o-m-halyard-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
VA, GA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of O&M HALYARD INC have?
Class II: 6 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of O&M HALYARD INC?
FDA event 98805, which the firm started on 13 Apr 2026. The first product in the record is: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
How many FDA recalls of O&M HALYARD INC have the status Ongoing?
7 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.