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HEALTHMARK INDUSTRIES CO., INC.

United States·US-MF-000047536

Last updated September 17, 2026

Information

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Instrument channel Brushes	GH-ICB-07041-3	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-07061-3	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-03030-3	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-21641-1	EUDAMED	Class I	Active
Vented Instrument Guards	GH-09-2-018	EUDAMED	Class I	Active
Cleaning Brushes	GH-200499-1	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-02746-50	EUDAMED	Class I	Active
Instrument channel Brushes	GH-ICB-08030-12	EUDAMED	Class I	Active

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 12, 2026	Z-1943-2026	—	open, classified	Product does not have FDA clearance.
May 2, 2025	Z-1910-2025	—	open, classified	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.
May 2, 2025	Z-1909-2025	—	open, classified	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.