Fraser, MI, United States
Healthmark Industries Co., Inc. recalls
4 recalls recorded since 2018, most recently on 7 September 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 September 2026
- Reason
- Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
- Distribution
- Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0188-2027
- Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE
Ongoing Class II Medical devices
- Recall started
- 29 July 2026
- Reason
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3031-2026, Z-3032-2026
- healthmark ProChek-II, Model Number PT-313, PT-201-12
- healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Ongoing Class II Medical devices
- Recall started
- 12 March 2026
- Reason
- Product does not have FDA clearance.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1943-2026
- Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Ongoing Class II Medical devices
- Recall started
- 2 May 2025
- 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 conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
- Distribution
- US Nationwide and Internationally to countries of: Canada, Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1910-2025, Z-1909-2025
- ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.