Pre-filled Water Syringes for endoscopes recalled due to contamination risk
Healthmark Industries recalls ChannelCheck Convenience Pack pre-filled water syringes after contamination was discovered during endoscope monitoring. The syringes were found to have been improperly used outside their intended purpose.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with contamination discovered during surveillance monitoring. No illnesses, injuries, or hospitalizations are reported in the source. The hazard is based on precautionary findings rather than confirmed adverse events.
Plain-English summary
Healthmark Industries Co., Inc. is recalling ChannelCheck Convenience Pack Model Numbers UCC-222CP and UCC-222-ESP (approximately 193,035 units) due to contamination discovered in the Pre-filled Water Syringes used with endoscopes.
During endoscope surveillance monitoring, a user facility identified contamination in duodenoscope samples that was linked to the Pre-filled Water Syringes. Healthmark Industries' investigation determined that the syringes had been improperly used outside their intended purpose.
The affected products were distributed nationwide in the United States and internationally to Canada and Malaysia, with multiple lot numbers involved.
Healthcare facilities and users should cease use of the affected products immediately and contact Healthmark Industries for further instructions.
The recalled product
- Product
- ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- Manufacturer
- Healthmark Industries Co., Inc.
- Hazard
- contamination
- improper-use
- medical-device-contamination
Distribution
Distributed nationwide across the United States.
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