Every recall we track for Karl Storz Endoscopy — 69 in all — plus the complaints and injury reports the public filed about them.
Karl Storz recalls flexible hystero-fiberscope kits with expired single-use endoscopic seals for gynecology procedures, which could compromise sterility during medical use.
Karl Storz recalls optical biopsy and grasping forceps (REF 723400) due to potential sterility failure. All lots of affected material number 04048551194416 are impacted. Consumers should contact Karl Storz for details.
Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. This may pose safety risks if used without FDA-reviewed procedures. Affected units have specific serial numbers and were sold with CE 0123 certification.
Karl Storz recalls ureteroscopes with model 27010K (7Fr, 34cm) due to unapproved reprocessing methods. This could pose safety risks during medical use. Affected units include specific lots with UDI 04048551231319.
Karl Storz recalls ureteroscopes with unapproved reprocessing methods that may not meet FDA safety standards. Affected models include 27011K (8 Fr., 6.5mm, 34cm) sold globally. Consumers should contact Karl Storz for details.
Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. This device requires FDA-reviewed reprocessing to prevent safety risks. Affected units have specific serial numbers.
Karl Storz recalls ureteroscopes with model 27000K due to unapproved reprocessing methods. This could pose safety risks if used without FDA-reviewed procedures. Affected units sold with CE 0123 marking.
Karl Storz recalls ureteroscopes with model 27002K due to unapproved reprocessing methods that may not meet FDA safety standards. Affected units include specific lots and serial numbers.
Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods that could pose safety risks. Affected units have specific serial numbers and were sold with CE 0123 certification.
Karl Storz recalls pediatric ureterorenoscope models with unapproved reprocessing methods that may not meet FDA safety standards. Affected units include specific serial numbers and lots.
Karl Storz recalls pediatric cysto-urethroscopes with unapproved reprocessing methods that could pose safety risks. Affected models include REF: 27030KB, all lots/UDI: 04048551:232118.
Karl Storz recalls ureteroscopes with model 27001K due to unapproved reprocessing methods. This could pose safety risks if used without FDA-reviewed procedures. Affected units include specific lots and serial numbers.
Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods. FDA requires safety review before use. Affected units include specific lot numbers.
Karl Storz recalls cysto-urethroscopes with model 27030KA due to unapproved reprocessing methods that could pose safety risks. Affected units include specific lots and UDI numbers.
Karl Storz recalls ureterorenoscopes with unapproved reprocessing methods that may pose safety risks. Affected models include 27003L (9.5 Fr., 43cm) sold with CE0123 marking. Consumers should contact Karl Storz for details.
Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods that may pose safety risks. Affected units include specific lot numbers and CE 0123 marked devices.
Karl Storz recalls irrigation tubing for Endomat Select UP210 models due to improper FDA labeling. This affects specific product numbers sold in the U.S. No immediate action needed as the hazard is labeling-related.
Karl Storz recalls nephrosopes with unapproved reprocessing methods that may not be safe for medical use. Affected units have specific serial numbers.
Karl Storz recalls nephrosopes with unapproved reprocessing methods that may not be safe for medical use. Affected models include REF: 27840KA, CE 0123.
Karl Storz recalls endoscopy devices with unapproved reprocessing methods that may not meet FDA safety standards. Affected products include specific models sold under CE 0123 certification.
Karl Storz recalls specific endoscopy devices due to unapproved reprocessing methods that may not meet FDA safety standards. Affected devices include Hopkins Telescope 6 models with certain serial numbers.
Karl Storz recalls endoscopy devices with unapproved reprocessing methods that may not meet FDA safety standards. Affected devices include specific models sold under CE 0123 certification.
Karl Storz recalls endoscopy devices with unapproved reprocessing methods. FDA requires safety review before use. Affected devices include specific models and lots.
Karl Storz recalls Endoskope Telescope 6 devices with unapproved reprocessing methods. FDA requires safety review before use to prevent risks.
Karl Storz recalls endoscopy devices with unapproved reprocessing methods. FDA requires safety review before use. Affected devices include specific models and lots.
Karl Storz Endoscopy recalls two laser surgical instruments due to lack of validated reprocessing methods, increasing infection risk after reuse. Affected models include REF 8694 and 461000.
Karl Storz Endoscopy recalls flexible 1mm grasping forceps (UDI: 04048551050255) due to inadequate reprocessing validation evidence. Affected units include all lots sold.
Karl Storz Endoscopy recalls veterinary uvula retractors (UDI: 04048551193587) due to inadequate reprocessing validation evidence. Affected units sold for veterinary use only with prescription.
Karl Storz recalls optical scissors (UDI: 04048551259788) due to inadequate reprocessing validation evidence. Affected units may not be safely reused.
Karl Storz Endoscopy recalls injection needles with REF 25207 due to potential infection risk from inadequate cleaning. Affected units may expose patients to higher infection risks during surgery.
Karl Storz recalls injection needles for surgery due to unverified cleaning process risking patient infections. Affected models include LUER-lock, 0.8mm, REF: 26175PD.
Karl Storz recalls specific injection needles for general and visceral surgery due to potential infection risks from inadequate cleaning. Affected models include 70-degree and 80-degree needles with certain serial numbers.
Karl Storz Endoscopy recalls curved and straight 23cm injection needles (REFs 8598A/B/D) due to potential infection risk from inadequate cleaning during surgery. Affected items may expose patients to higher infection risks if used without proper cleaning.
Karl Storz Endoscopy recalls injection needles and cannulas due to potential infection risk from inadequate cleaning. Affected items may expose patients to higher infection risks during surgery.
Karl Storz recalls five S 5 3x6: sterility not confirmed. Affected units have UDI 04048551446690. Consumers should check if they own these specific sterile endoscopes.
Karl Storz recalls specific metal sterilization trays due to new 510(k) instructions for use that may require updated sterilization methods. Affected trays have unique dimensions and reference numbers.
Karl Storz recalls specific sterilization trays due to new 510(k) instructions that may not be fully compatible with sterilization processes. Affected models include 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, and 39317A.
Karl Storz recalls specific CMOS video cysto-urethroscopes that may lose image when using monopolar electrocautery due to a manufacturing issue. Affected models include REF 11272VUE and REF 11272VUEK with listed serial numbers.
Karl Storz recalls specific ureteroscope models due to failure to reduce microorganisms during disinfection. Affected units may not be safe for medical use after cleaning.
Karl Storz recalls certain flexible video urethro cystoscopes from 2018 due to failure to reduce microorganisms during disinfection. Affected models may not be safe for medical use.
Karl Storz recalls Slim Nasopharyngolaryngoscopes from 2018 with disinfection failure risk. Products may not reduce microorganisms as expected after cleaning.
Karl Storz recalls flexible video cysto-urethroscopes with serial numbers from January 2018 due to failure to achieve six-log reduction in microorganisms after disinfection. Consumers should contact Karl Storz for details.
Karl Storz recalls flexible cystoscopes from 2018 with disinfection failure risk. Products may not reduce microorganisms to six log levels after cleaning.
Karl Storz recalls certain flexible ureteroscopes due to failure to achieve six-log reduction in microorganisms after disinfection. Affected models include 11278VSA, 11278VSE, 11278VSU, 11278VSUA, and 11278VSUE series with specific UDI codes and production dates from January 2018 onward.
Karl Storz recalls certain flexible ureteroscopes that may not achieve required disinfection, risking infection during medical procedures. Affected models include 11278VSA, 11278VSE, 11278VSU, and 11278VSUA/VSUE with specific serial dates.
Karl Storz recalls certain cystoscopy scopes that may not achieve expected six-log reduction in microorganisms after disinfection, posing infection risks during medical procedures.
Karl Storz recalls HD-VIEW flexible cysto-urethroscopes from 2018-2021 with disinfection failure risk. Products may not reduce microorganisms as expected after cleaning.
Karl Storz recalls adult cystoscopes with serial numbers from January 2018 due to failure to achieve six-log reduction in microorganisms after disinfection.
Karl Storz recalls specific flexible ureteroscope models from 2016-2018 due to failure to reduce microorganisms during disinfection, posing infection risks during medical procedures.
Karl Storz recalls flexible bronchoscopes from 2018-2019 with potential inadequate disinfection, risking infection. Affected units have specific serial numbers and UDI codes.
Karl Storz recalls specific sterilization trays with outdated instructions that may affect sterilization effectiveness. Updated instructions now specify compatible endoscope sizes and exclude ethylene oxide as a sterilization method.
Karl Storz recalls 7 flexible intubation video scopes due to potential infection risk from inadequate sterility. Affected models include REF: 091361-01 (1 unit) and 091361-06 (6 units).
Karl Storz recalls flexible intubation endoscopes with model 11301BNX that may not be properly sterilized, risking patient infection if ethylene oxide is used on certain models.
Karl Storz recalls flexible DCI intubation fiberscopes with part number 11301BND1 due to infection risk from improper sterilization. Updated instructions prevent using certain trays and ethylene oxide gas.
Karl Storz recalls flexible intubation endoscopes with model 11302BDX that may not be sterilized properly, risking patient infections. Owners should check if their device has the specified model and follow official instructions.
Karl Storz recalls flexible intubation endoscopes with model 1130:11303BNX that may not be properly sterilized, risking patient infection if ethylene oxide is used on certain models.
Karl Storz recalls flexible intubation fiberscopes with model 11302BD2 that may not be properly sterilized, risking patient infections if not handled correctly.
Karl Storz recalls flexible intubation fiberscopes with part number 11301AA1 due to risk of infection from incomplete sterilization. Updated instructions prevent using certain sterilization trays and ethylene oxide gas.
Karl Storz recalls flexible DCI intubation fiberscopes with model 11302BDD2 due to risk of infection from improper sterilization. Updated instructions prevent using certain trays and ethylene oxide gas.
