Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Healthmark Industries Co., Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Product Codes/Lot Numbers:
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1909-2025
Related Recalls
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Healthmark Industries Co.
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.