Food, drugs, devices › O&M HALYARD, INC.
Device recall: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code
FDA enforcement event 92942 is a device recall by O&M HALYARD, INC. of Mechanicsville, VA, initiated 9 Aug 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. O&M HALYARD, INC. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
O&M HALYARD, INC., Mechanicsville, VA.
Reason for recall
"One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user."
Distribution
"US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2626-2023 | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 | 41790 masks | Class II | Ongoing | 27 Sep 2023 |
Context
Other enforcement events for O&M HALYARD, INC.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Apr 2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 4 | Device | Class II | 1 |
| 17 Jul 2025 | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 | Device | Class II | 1 |
| 26 Nov 2024 | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: | Device | Class II | 1 |
| 8 Nov 2024 | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 | Device | Class II | 2 |
| 20 Feb 2024 | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | Device | Class III | 1 |
| 27 Sep 2021 | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | Device | Class II | 1 |
All 7 events for O&M HALYARD, INC.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.