FDA (Devices) recall action 89880

Karl Storz Endoscopy recalled 10 products on 2022-05-18

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2022-05-18
Critical: 0
Units: 20,180

Why these products were recalled

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

HighFDA (Devices)··2022-05-18
Flexible video uretero-renoscopes recalled for inadequate sterilization
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.
Product
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
Cysto-Urethroscope Disinfection Process Failure Affects Serial Numbers Since 2018
Karl Storz Endoscopy is recalling Flexible Video Cysto-Urethroscopes due to a disinfection process failure that may not adequately eliminate microorganisms. Affected units have been distributed nationwide and internationally since January 2018.
Product
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
Flexible Uretero-Renoscopes Recalled for Inadequate Disinfection
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.
Product
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
Flexible Cystoscopes Recalled for Inadequate Disinfection Process
Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.
Product
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
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.
Product
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
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.
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
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
Karl Storz cystoscopes recalled due to inadequate disinfection
Karl Storz cystoscopes manufactured since January 2018 are recalled because they may not achieve required disinfection levels. Inadequate disinfection could lead to patient infection during urological procedures.
Product
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
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.
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)
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
CMOS Video Cysto-Urethroscope Disinfection Failure Puts Patients at Infection Risk
Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.
Product
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
Category
Distribution
52 states
HighFDA (Devices)··2022-05-18
Karl Storz Video Ureteroscopes May Not Be Properly Sterilized
Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.
Product
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
Category
Distribution
52 states