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Karl Storz Endoscopy Recalls
71 recalls on record · July 16, 2014 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-d
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, REF: 25207
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
September 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Hazard: Flexible intubation endoscopes sterility assurance can not be confirmed.
June 28, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm,
Hazard: Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
June 28, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Hazard: Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
June 15, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-
Hazard: The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cys
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW F
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-UR
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
May 18, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Hazard: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
January 5, 2022Medical DevicesFDA
Karl Storz Endoscopy recalls Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, I
Hazard: To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
November 10, 2021Medical DevicesFDA
Karl Storz Endoscopy recalls FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Hazard: During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be us
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be us
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
September 2, 2020Medical DevicesFDA
Karl Storz Endoscopy recalls Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to
Hazard: Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.