Karl Storz Endoscopy
Complete recall history across all FDA and CPSC categories — 70 total recalls
Karl Storz Endoscopy appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (70)
FDA medical device enforcement actions by Karl Storz Endoscopy. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 19, 2024 | Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE | Due to failure of manual cleaning validation, biopsy and grasping forceps lik... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON ... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE,... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, N... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STER... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON ... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NO... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERI... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm,... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STER... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/... | Class II |
| Oct 21, 2024 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... | Due to improper labeling of products. An intended use on the label has not be... | Class II |
| Oct 11, 2024 | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... | Due to holes detected in the inner barrier system that may compromise the ste... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that hav... | Class II |
| Apr 1, 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... | Laser surgical instruments have no specific evidence of a validated reprocess... | Class II |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only | Inadequate reprocessing validation evidence | Class II |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only,... | Inadequate reprocessing validation evidence | Class II |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE | Inadequate reprocessing validation evidence | Class II |
| Oct 24, 2023 | Injection Needle, REF: 25207 | The efficacy of the manual cleaning process cannot be assured for the affecte... | Class II |
| Oct 24, 2023 | Injection Needle, LUER-lock,0.8mm, REF: 26175PD | The efficacy of the manual cleaning process cannot be assured for the affecte... | Class II |
| Oct 24, 2023 | Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing... | The efficacy of the manual cleaning process cannot be assured for the affecte... | Class II |
| Oct 24, 2023 | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm... | The efficacy of the manual cleaning process cannot be assured for the affecte... | Class II |
| Oct 24, 2023 | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A | The efficacy of the manual cleaning process cannot be assured for the affecte... | Class II |
| Jul 7, 2023 | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only | Flexible intubation endoscopes sterility assurance can not be confirmed. | Class II |
| Apr 6, 2023 | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... | Metal sterilization trays used to encase and protect medical devices during s... | Class II |
| Apr 5, 2023 | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... | Plastic sterilization trays used to encase and protect medical devices during... | Class II |
| May 3, 2022 | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF... | The endoscope may experience a loss of image when activating monopolar electr... | Class II |
| Apr 1, 2022 | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VA... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/20... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF ... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A F... | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
| Apr 1, 2022 | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) | Failure to achieve the expected six-log reduction in microorganisms following... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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