Karl Storz Flexible Video Urethro Cystoscope Recalled for Inadequate Disinfection
Karl Storz is recalling multiple Flexible Video Urethro Cystoscope models because they may fail to achieve proper disinfection between procedures, posing a risk of microbial contamination.
What this means for you
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: FDA Class II recall of an invasive medical device where the disinfection mechanism failure poses a risk of microbial transmission to patients. No illnesses or injuries are reported in the source text, placing this at the High level per the risk-of-harm criterion.
Plain-English summary
Karl Storz Endoscopy is recalling Flexible Video Urethro Cystoscope models 11272VN, 11272VNK, 11272VNU, and 11272VNUK (manufactured and distributed since January 2018) due to a disinfection failure issue.
The devices may fail to achieve the expected reduction in microorganisms during the disinfection process, meaning they may not be adequately disinfected between patient uses.
The recalled devices were distributed throughout the United States and internationally to Mexico, Lebanon, and South Korea. The recall affects all serial numbers of the specified model numbers manufactured or distributed since January 2018.
Healthcare providers should discontinue use of the affected devices and contact Karl Storz Endoscopy regarding return, replacement, or further instructions. Patients who had procedures using these devices should consult their healthcare provider if they have concerns about potential exposure.
The recalled product
- Product
- 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 2,018
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers manufactured/distributed since January 2018.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Karl Storz Endoscopy 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.
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