Flexible Ureteroscope Recall Due to Inadequate Disinfection Process
Karl Storz Endoscopy is recalling flexible ureteroscopes manufactured or distributed since January 2018 due to the disinfection process failing to achieve expected microbial reduction levels.
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 a risk-of-harm product (invasive medical device used in sterile procedures) where disinfection failure creates a potential infection hazard. No illnesses or injuries have been reported in the source text, which limits the score to a maximum of 3 per the rubric.
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of flexible ureteroscopes used in urological procedures. The devices are being recalled because they have not been achieving the expected six-log (99.9999%) reduction in microorganisms following the disinfection process.
This ureteroscope is an invasive medical device used in sterile urological procedures. Inadequate disinfection can result in residual microbial contamination that poses a patient infection risk.
The recall affects all serial numbers of the affected ureteroscope models manufactured or distributed since January 2018. Distribution includes the United States (all states plus DC and Guam), Mexico, Lebanon, and South Korea.
Patients and healthcare providers with affected ureteroscopes should contact Karl Storz Endoscopy for instructions on device return, replacement, or updated disinfection procedures.
The recalled product
- Product
- 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Ureteroscope
- Hazard
- disinfection-failure
- contamination-risk
- infection-risk
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 (2)
- 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353
- 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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