Karl Storz Endoscopy recalls
17 official recalls and safety alerts involving Karl Storz Endoscopy since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Karl Storz Endoscopy or the relevant agency.
- 2026-10-07
USKarl Storz Endoscopy recalls HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…
Due to incorrect inside packaging label for eyepiece.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of AZ, CA and MO.Official notice →- 2026-07-29
- US
Karl Storz Endoscopy recalls Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI,…Official notice → - 2025-02-05
- US
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-01-22
- US
Karl Storz Endoscopy recalls Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
FDA · DeviceKarl Storz EndoscopyUS: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN,…Official notice → - 2024-12-04
- US
Karl Storz Endoscopy recalls 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF…
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
FDA · DeviceKarl Storz EndoscopyWorldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS,…Official notice → - 2024-11-20
- US
Karl Storz Endoscopy recalls Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY,…Official notice → - 2024-10-02
- US
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2024-05-22
- US
Karl Storz Endoscopy recalls LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then…
FDA · DeviceKarl Storz EndoscopyWorldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX,…Official notice → - 2024-04-10
- US
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Inadequate reprocessing validation evidence
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA,…Official notice → - 2023-12-27
- US
Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
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.
FDA · DeviceKarl Storz EndoscopyUS: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI,…Official notice → - 2023-09-27
- US
Karl Storz Endoscopy recalls Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Flexible intubation endoscopes sterility assurance can not be confirmed.
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2023-06-28
- US
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, REF: 11580C; Metal…
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…
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of IN, MS, MN,…Official notice → - US
Karl Storz Endoscopy recalls KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
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…
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AR, AZ,…Official notice → - 2022-06-15
- US
Karl Storz Endoscopy recalls STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF…
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
FDA · DeviceKarl Storz EndoscopyWorldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-05-18
- US
Karl Storz Endoscopy recalls 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC,…Official notice → - 2022-01-05
- US
Karl Storz Endoscopy recalls Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA…
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…
FDA · DeviceKarl Storz EndoscopyUS: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…Official notice → - 2021-11-10
- US
Karl Storz Endoscopy recalls FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
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…
FDA · DeviceKarl Storz EndoscopyUS: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN,…Official notice →