FDA Medical devices recall ·
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP… recall
- Recall number
- Z-1910-2025
- 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
- 193035 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
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: 200014 200015 200016 900153 900154 900155 900156 900157 900158 900159 900160 900161 900162 900163 900164 900165 900166 900167 900168 900169 900170 900171 900172 900173 900174 900175 900176 900177 103564 103312 103293 102807 102096 101673
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-1910-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.