CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
ChannelCheck Convenience Pack recalled by Healthmark Industries Co
Healthmark Industries is recalling ChannelCheck Convenience Pack, distributed nationwide in the US. The recall was initiated on 2 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1910-2025
- FDA event ID
- 96823
- Recalling firm
- Healthmark Industries, Fraser, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2025
- FDA classified
- 5 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 May 2025 | Recall initiated by company | |
| 5 Jun 2025 | Classified by FDA | +34 days |
| 11 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Where it was distributed
US Nationwide and Internationally to countries of: Canada, Malaysia.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
US Nationwide and Internationally to countries of: Canada, Malaysia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96823| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pre-filled Water Syringe recalled by Healthmark Industries Co | Healthmark Industries | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | healthmark ProChek-W Protein Test for Robotic Arms recalled | Healthmark Industries | Other | Nationwide |
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