Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
FDA Recall #Z-1909-2025 — Class II — May 2, 2025
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.
Recalling Firm
Healthmark Industries Co., Inc. — Fraser, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
250000 units
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Code Information
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated