Pre-filled Water Syringe recall: Contamination
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Why was Pre-filled Water Syringe 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
- Product
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Recalling firm
- Healthmark Industries Co., Inc.
- Quantity
- 250000 units
- Distribution
- US Nationwide and Internationally to countries of: Canada, Malaysia.
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)