Healthmark Industries Co., Inc.: Device Recall

Recall #Z-1909-2025 · 05/02/2025

Class II: Risk

Recall Details

Recall Number: Z-1909-2025
Classification: Class II
Product Type: Device
Recalling Firm: Healthmark Industries Co., Inc.
Status: Ongoing
Date Initiated: 05/02/2025
Location: Fraser, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 250000 units

Reason for Recall

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.

Product Description

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

Distribution Pattern

US Nationwide and Internationally to countries of: Canada, Malaysia.

Other Recalls by Healthmark Industries Co., Inc.

Class II: Risk 05/02/2025

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.

View all recalls by Healthmark Industries Co., Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.