FDA-Device2025-06-11Class II
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Healthmark Industries Co., Inc.
Hazard
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.
Sold states
US Nationwide and Internationally to countries of: Canada, Malaysia.
Affected count
193035 units
Manufactured in
18600 Malyn Blvd, N/A, Fraser, MI, United States
Products
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1910-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief