Healthmark Industries recalls

Healthmark Industries appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011
  FDA Device · Class II · 2026-10-21 · Healthmark Industries
  Reason: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
• healthmark ProChek-W Protein Test for Robotic Arms
  FDA Device · Class II · 2026-09-02 · Healthmark Industries
  Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
• healthmark ProChek-II, Model Number PT-313, PT-201-12
  FDA Device · Class II · 2026-09-02 · Healthmark Industries
  Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
• Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
  FDA Device · Class II · 2026-05-06 · Healthmark Industries
  Reason: Product does not have FDA clearance.
• ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
  FDA Device · Class II · 2025-06-11 · Healthmark Industries
  Reason: 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 conduc…
• Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
  FDA Device · Class II · 2025-06-11 · Healthmark Industries
  Reason: 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 conduc…