ChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
Healthmark Industries is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes (Models UCC-222CP and UCC-222-ESP) because contamination was found in duodenoscope samples linked to the syringes, which were improperly used outside their intended purpose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving potential contamination in a medical device used in endoscopy procedures. The source text does not report any illnesses or injuries, but the hazard involves microbial contamination linked to duodenoscope samples, which presents a risk of harm even though no adverse health consequences have been reported yet, meeting the High criterion for risk-of-harm products without reported illness.
Plain-English summary
Healthmark Industries Co., Inc. is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes, Model Numbers UCC-222CP and UCC-222-ESP (Sample). A user facility identified contamination in duodenoscope samples that were linked to these Pre-filled Water Syringes during endoscope surveillance monitoring.
Healthmark Industries conducted an investigation and concluded that the Pre-filled Water Syringes had been improperly used outside of their intended purpose. The recall affects approximately 193,035 units distributed nationwide in the United States and internationally to Canada and Malaysia.
Affected lot numbers include: 200014, 200015, 200016, 900153-900177, and 103564, 103312, 103293, 102807, 102096, 101673.
Users who have these syringes should discontinue use and contact Healthmark Industries for further instructions regarding the recalled product.
The recalled product
- Product
- ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- Manufacturer
- Healthmark Industries Co., Inc.
- Affected units
- 193,035
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Healthmark Industries Co., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Healthmark Industries Co., Inc.
See all →- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighMesh Style Tip Protectors recalled lacking FDA clearance
FDA (Devices) · 2026-05-06
- ModeratePre-filled Water Syringe recalled for improper use contamination
FDA (Devices) · 2025-06-11
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighMedline Medical Convenience Kits Recalled Due to Syringe Quality Issues
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Convenience Kits Recalled Due to Leaks and Breakage in Syringes
FDA (Devices) · 2024-09-18
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29
- HighMedline Medical Convenience Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2025-03-26
- HighMedline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
FDA (Devices) · 2024-09-18