Karl Storz HD Cysto-Urethroscope recalled for disinfection failure
Karl Storz is recalling HD-VIEW Flexible HD Cysto-Urethroscope models that fail to adequately disinfect during processing, creating a potential infection risk. All units manufactured since January 2018 are affected.
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: This is an FDA Class II medical device recall for failure of the disinfection process, which presents a documented risk of patient infection. However, the source text contains no reports of illnesses or injuries, which keeps the severity at High rather than Severe.
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of the HD-VIEW Flexible HD Cysto-Urethroscope (models 11272VH-TL, 11272VHK-TL, 11272VHU-TL, and 11272VHUK-TL) manufactured since January 2018.
The devices are being recalled because they fail to achieve the expected six-log (99.9999%) reduction in microorganisms during the disinfection process. Inadequate disinfection could leave residual microbial contamination on the instrument surface, posing a potential infection risk to patients undergoing urological procedures.
The affected devices have been distributed throughout the United States and internationally to Mexico, Lebanon, and South Korea. Healthcare facilities and medical professionals who have received these instruments should cease use and contact Karl Storz Endoscopy for information on corrective actions or replacement options.
The recalled product
- Product
- 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- disinfection-failure
- infection-risk
- microbial-contamination
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
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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