FDAMay 2, 2025device
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
healthmark
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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