Reported Jun 11, 2025 · Ongoing
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Healthmark Industries Co., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Healthmark Industries Co., Inc. · 18600 Malyn Blvd · Fraser, MI · 48026-3496
Is this the product you have?
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Lot codes and dates
- Lot Numbers
200001200002200003200004200005200006200007200008200009200010200011200012200013
- Lot Numbers
- Amount recalled
- 250000 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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