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O&M HALYARD, INC.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
22
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2520-2025Class IIOrthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902BJuly 17, 2025
Z-0983-2025Class IIBrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: NNovember 26, 2024
Z-0729-2025Class IIO&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500November 8, 2024
Z-0728-2025Class IIO&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47November 8, 2024
Z-1461-2024Class IIIHALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)February 20, 2024
Z-2626-2023Class IIFLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, sizeAugust 9, 2023
Z-0317-2022Class IIHALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XLSeptember 27, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsDecember 11, 2025
K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with August 18, 2025
K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free June 18, 2025
K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with CheDecember 17, 2024
K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with ChemoSeptember 27, 2024
K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIALSeptember 16, 2024
K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)August 7, 2024
K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with CheMarch 22, 2024
K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with ChemAugust 16, 2022
K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl CitAugust 1, 2022
K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam GlovesJune 2, 2022
K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam GlovesJune 2, 2022
K203177Sterisystem Dry-Base Instrument TrayJanuary 2, 2022
K211063HALYARD Flexaprene Green Powder-Free Exam GloveNovember 19, 2021
K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable PerformanceJuly 21, 2021
K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with ChemotherapyJanuary 7, 2021
K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy DrugsSeptember 22, 2020
K200522AERO CHROME* Breathable Performance Surgical GownsMarch 16, 2020
K192362Aero Blue Performance Surgical GownsDecember 13, 2019
K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-FNovember 8, 2019