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Healthmark Industries CO INC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000047536

Devices
288
Registrations
EUDAMEDFDA
FDA recalls
66 ongoing

Catalogue288

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Company details

EUDAMED SRN
US-MF-000047536
DUNS number
057680480
EUDAMED status
Active
EUDAMED registered name
Healthmark Industries CO INC
Registered address
18600 Mayln Blvd, 48026, Fraser, United States
Phone
+15867747600
PRRC contact
Jamie Chenard(public in EUDAMED)

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 2
  • 2026 4

  • 2026

    • 7 Sep 2026 Z-0188-2027 Class II Ongoing Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO…
      Full distribution text Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
    • 29 Jul 2026 Z-3031-2026 Class II Ongoing Test manufactured with an expired ingredient which may present as either a false negative or positive.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
    • 29 Jul 2026 Z-3032-2026 Class II Ongoing Test manufactured with an expired ingredient which may present as either a false negative or positive.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
    • 12 Mar 2026 Z-1943-2026 Class II Ongoing Product does not have FDA clearance.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: US Nationwide distribution.

  • 2025

    • 2 May 2025 Z-1909-2025 Class II Ongoing During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: US Nationwide and Internationally to countries of: Canada, Malaysia.
    • 2 May 2025 Z-1910-2025 Class II Ongoing During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.via FDA establishment HEALTHMARK INDUSTRIES CO., INC. Distribution: US Nationwide and Internationally to countries of: Canada, Malaysia.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Healthmark Industries Co., Inc. Fraser, MI · US FEI 1000160387

From the company website

Read 18 Oct 2026

Healthmark Industries provides medical and surgical equipment such as cleaning verification tests, trays, containers, bins, carts and packaging for the sterilization, decontamination, storage, distribution and security of medical and surgical equipment and supplies.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Healthmark Industries CO INC have in the registry?

The registry currently lists 288 devices for Healthmark Industries CO INC. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Healthmark Industries CO INC?

FDA recall records list 6 recalls initiated by Healthmark Industries CO INC, the most recent initiated on 7 Sep 2026. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

Which FDA establishments are linked to Healthmark Industries CO INC?

1 FDA establishment is linked to Healthmark Industries CO INC in the registry; they are listed on the company page.

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