O&M HALYARD INC
FDA Regulatory Profile
O&M HALYARD INC appears in FDA public data with 8 recalls, 25 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2230-2026, Class II) was initiated on April 13, 2026. Its most recent 510(k) clearance was granted on July 2, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 25
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2230-2026 | Class II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 | April 13, 2026 |
| Z-2520-2025 | Class II | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B | July 17, 2025 |
| Z-0983-2025 | Class II | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N | November 26, 2024 |
| Z-0729-2025 | Class II | O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500 | November 8, 2024 |
| Z-0728-2025 | Class II | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47 | November 8, 2024 |
| Z-1461-2024 | Class III | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | February 20, 2024 |
| Z-2626-2023 | Class II | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size | August 9, 2023 |
| Z-0317-2022 | Class II | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | September 27, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilizat | July 2, 2026 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL | May 18, 2026 |
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* | March 18, 2026 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | December 11, 2025 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with | August 18, 2025 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free | June 18, 2025 |
| K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Che | December 17, 2024 |
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemo | September 27, 2024 |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL | September 16, 2024 |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | August 7, 2024 |
| K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Che | March 22, 2024 |
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chem | August 16, 2022 |
| K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Cit | August 1, 2022 |
| K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | June 2, 2022 |
| K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | June 2, 2022 |
| K203177 | Sterisystem Dry-Base Instrument Tray | January 2, 2022 |
| K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | November 19, 2021 |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance | July 21, 2021 |
| K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy | January 7, 2021 |
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | September 22, 2020 |