Healthmark Industries Co., Inc. Recalls
5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (5)
- Class II
July 29, 2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Class II
July 29, 2026
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Class II
March 12, 2026
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Product does not have FDA clearance.
- Class II
May 2, 2025
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
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.
- Class II
May 2, 2025
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
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.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.