Recall Z-1909-2025— Healthmark Industries Co., Inc.
Class II · Ongoing
Class II FDA medical device recall by Healthmark Industries Co., Inc., initiated 2025-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010. 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..
- Recalling firm
- Healthmark Industries Co., Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-02
- Firm location
- Fraser, MI, United States
Product description
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.