FDA Medical devices recall ·
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 recall
- Recall number
- Z-1909-2025
- Date
- (initiated May 2, 2025)
- Company / brand
- Healthmark Industries Co., Inc.
18600 Malyn Blvd, Fraser, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 250000 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1909-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.