Chrysalis Intelligence · Sponsors · O&M Halyard, Inc.

O&M Halyard, Inc.

Alpharetta, GA, US · 22 510(k) clearances · 7 recalls

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Total clearances
22
2020-03-16 → 2026-07-21
Last 12 months
5
Product codes
5
Most recent
2026-07-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZA — — — 13 2026-07-21
FRG Wrap, Sterilization Class II General Hospital 4 2026-07-02
FXX — — — 2 2026-03-18
FYA Gown, Surgical Class II General, Plastic Surgery 2 2021-07-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2022-01-02
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
7
Most recent
2025-07-17
DateSeverityStatusRecall # ProductCodeReason
2025-07-17 Class II Ongoing Z-2520-2025 Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 — Surgical drape packs may have open seals, which may compromise the sterility of the product.
2024-11-26 Class II Ongoing Z-0983-2025 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript… — Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
2024-11-08 Class II Ongoing Z-0729-2025 O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500 — Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this…
2024-11-08 Class II Ongoing Z-0728-2025 O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 — Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this…
2024-02-20 Class III Ongoing Z-1461-2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) — Product was mislabeled as a Surgical Cap at its dispenser level.
2023-08-09 Class II Ongoing Z-2626-2023 FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code… — One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
2021-09-27 Class II Ongoing Z-0317-2022 HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL — All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Filings

All 510(k) clearances (22)

Date K-number Device Code Class Specialty
2026-07-21 K262014 PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves LZA — —
2026-07-02 K261897 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology FRG Class II General Hospital
2026-05-18 K253454 HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap FRG Class II General Hospital
2026-03-18 K251967 HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor FXX — —
2025-12-11 K252941 HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops FXX — —
2025-08-18 K243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid LZA — —
2025-06-18 K243172 Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles LZA — —
2024-12-17 K242558 Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid LZA — —
2024-09-27 K241909 Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid LZA — —
2024-09-16 K234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap FRG Class II General Hospital
2024-08-07 K240330 HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) FRG Class II General Hospital
2024-03-22 K231938 Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid LZA — —
2022-08-16 K213937 Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution LZA — —
2022-08-01 K213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid LZA — —
2022-06-02 K220547 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves LZA — —
2022-06-02 K220541 PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves LZA — —
2022-01-02 K203177 Sterisystem Dry-Base Instrument Tray KCT Class II General Hospital
2021-11-19 K211063 HALYARD Flexaprene Green Powder-Free Exam Glove LZA — —
2021-07-21 K210688 AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown FYA Class II General, Plastic Surgery
2021-01-07 K202622 Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate LZA — —
2020-09-22 K200843 Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs LZA — —
2020-03-16 K200522 AERO CHROME* Breathable Performance Surgical Gowns FYA Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence