Healthmark Industries Co., Inc. FDA Recalls

5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
healthmark ProChek-II, Model Number PT-313, PT-201-12Class IIJul 29, 2026Test manufactured with an expired ingredient which may prese	Test manufactured with an expired ingredient which may present as either a false negative or positive.	Class IIDevices	Jul 29, 2026
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001Class IIJul 29, 2026Test manufactured with an expired ingredient which may prese	Test manufactured with an expired ingredient which may present as either a false negative or positive.	Class IIDevices	Jul 29, 2026
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styleClass IIMar 12, 2026Product does not have FDA clearance.	Product does not have FDA clearance.	Class IIDevices	Mar 12, 2026
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010Class IIMay 2, 2025During endoscope surveillance monitoring, a user facility id	During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples t	Class IIDevices	May 2, 2025
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)Class IIMay 2, 2025During endoscope surveillance monitoring, a user facility id	During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples t	Class IIDevices	May 2, 2025