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Healthmark Industries CO INC

United States Last updated 25 Oct 2026

Devices
288
Registries
EUDAMEDGUDIDFDA
FDA recalls
66 ongoing

Catalogue288

Page 1 of 6

Showing 1-50 of 288

FDA recalls6

Device pages show only the recalls that name the device or its 510(k)/PMA.

  • 2026

    • 7 Sep 2026 Z-0188-2027 Not yet classified Ongoing Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.via FDA establishment HEALTHMARK INDUSTRIES CO., INC.
    • 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.
    • 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.
    • 12 Mar 2026 Z-1943-2026 Class II Ongoing Product does not have FDA clearance.via FDA establishment HEALTHMARK INDUSTRIES CO., INC.

  • 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.
    • 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.

FDA establishments1

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

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

About

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.

Which registries list Healthmark Industries CO INC's devices?

Among its 50 most recently registered devices, Healthmark Industries CO INC has devices listed in FDA GUDID (50 devices).

What risk classes do Healthmark Industries CO INC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Healthmark Industries CO INC's devices are Class I and Class II. Each device page shows its own class and authorisation.

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 2026-09-07. 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.

What are the newest devices from Healthmark Industries CO INC in the registry?

The most recently registered devices listed for Healthmark Industries CO INC include SAFEGUARD PRO SGP112, SAFEGUARD PRO SGP115, SAFEGUARD PRO SGP118 and SAFEGUARD PRO SGP124.

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.

Information

Address
18600 Mayln Blvd, Fraser, United States
Phone
+15867747600
PRRC contact
Jamie Chenard
EUDAMED SRN
US-MF-000047536
DUNS number
057680480