Medical Device Recall: Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Healthmark Industries Co., Inc. · May 2, 2025
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.
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
States Affected
NATIONWIDE
Quantity Affected
250000 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1909-2025
Status: ongoing
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