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Halyard Health

Also registered as Halyard Health, Inc.

Country not established

Devices
14
FDA recalls
57

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Halyard Health makes

Halyard Health manufactures single-use medical gloves, including powder-free nitrile options in various colors and formulations, such as those tested for chemotherapy compatibility. The company also produces sterile single-step sterilization wraps and continuous nerve block kits, including echogenic catheter systems and associated pumps for regional anesthesia.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products cleared via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, and the company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

Newest first, rows 1-14 of 14

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Rows 1-14 of 14

FDA recalls57

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 57 recalls initiated by Halyard Health, the earliest on 2014-11-17 and the most recent on 2018-02-07. By recorded status: 57 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 10
  • 2018 3
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

44 initiated before 2017

Showing the 10 most recent of 57 recalls.

  • 2018

    • 7 Feb 2018 Z-1427-2018 Class II Terminated Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Distribution: Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL,…
      Full distribution text Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
    • 7 Feb 2018 Z-1428-2018 Class II Terminated Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Distribution: Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL,…
      Full distribution text Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
    • 7 Feb 2018 Z-1429-2018 Class II Terminated Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use. Distribution: Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL,…
      Full distribution text Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.

  • 2017

    • 13 Dec 2017 Z-1277-2018 Class II Terminated The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window. Distribution: Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany.…
      Full distribution text Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
      Submission number: K083210
    • 6 Oct 2017 Z-0117-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0118-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0119-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0120-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0121-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0122-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
Show the 25 most recent of 57 recalls

  • 2017

    • 6 Oct 2017 Z-0123-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0124-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV
    • 6 Oct 2017 Z-0125-2018 Class II Terminated Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents. Distribution: Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,…
      Full distribution text Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

  • 2016

    • 10 Nov 2016 Z-0758-2017 Class II Terminated Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. Distribution: CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT. Submission number: K081027
    • 9 Nov 2016 Z-0724-2017 Class II Terminated Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site. Distribution: US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY Submission number: K862801
    • 16 Jun 2016 Z-2391-2016 Class II Terminated Mismatch between the length of the RF electrode (probe) and the cannula (introducer), Distribution: Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada. Submission number: K053082

  • 2015

    • 29 Jul 2015 Z-2492-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2493-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2494-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2495-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2496-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2497-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2498-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2499-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
    • 29 Jul 2015 Z-2500-2015 Class II Terminated The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. Distribution: Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada

Frequently asked questions

How many devices does Halyard Health have in the registry?

The registry currently lists 14 devices for Halyard Health. Devices recorded under merged duplicate company entries are counted once.

Which registries list Halyard Health's devices?

Among its 14 most recently registered devices, Halyard Health has devices listed in FDA 510(k) (14 devices).

What risk classes do Halyard Health's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Halyard Health's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Halyard Health?

FDA recall records list 57 recalls initiated by Halyard Health, the most recent initiated on 2018-02-07. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Halyard Health in the registry?

The most recently registered devices listed for Halyard Health include HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves, Fluidshield* Surgical Mask with Expanded Chamber, KIMGUARD ONE STEP STERILIZATION WRAP and Halyard Black-Orange Powder-Free Nitrile Exam Glove.

Generated automatically from registry data and not verified by a human reviewer.