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Browse Device Recalls

87 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 87 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 87 FDA device recalls.

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DateProductReasonClassFirm
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 like sterility assurance. Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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/or approved for safe... Class II Karl Storz Endoscopy
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 been reviewed and appr... Class II Karl Storz Endoscopy
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 sterility of the affect... Class II Karl Storz Endoscopy
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 have not been reviewed ... Class II Karl Storz Endoscopy
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 have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
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 have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
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 have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... Class II Karl Storz Endoscopy
Jul 23, 2024 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 ... Class II Karl Storz Endoscopy
Apr 1, 2024 LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... Laser surgical instruments have no specific evidence of a validated reprocessing method, therefor... Class II Karl Storz Endoscopy
Feb 27, 2024 Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only Inadequate reprocessing validation evidence Class II Karl Storz Endoscopy
Feb 27, 2024 Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only,... Inadequate reprocessing validation evidence Class II Karl Storz Endoscopy
Feb 27, 2024 Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE Inadequate reprocessing validation evidence Class II Karl Storz Endoscopy
Oct 24, 2023 Injection Needle, REF: 25207 The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... Class II Karl Storz Endoscopy
Oct 24, 2023 Injection Needle, LUER-lock,0.8mm, REF: 26175PD The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... Class II Karl Storz Endoscopy
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 affected injection needles ... Class II Karl Storz Endoscopy
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 affected injection needles ... Class II Karl Storz Endoscopy
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 affected injection needles ... Class II Karl Storz Endoscopy
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 Karl Storz Endoscopy
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 sterilization have a ... Class II Karl Storz Endoscopy
Apr 5, 2023 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... Plastic sterilization trays used to encase and protect medical devices during sterilization have ... Class II Karl Storz Endoscopy
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 electrocautery, due a manu... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
Apr 1, 2022 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 ... Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
Apr 1, 2022 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
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 the disinfection pr... Class II Karl Storz Endoscopy
Apr 1, 2022 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) Failure to achieve the expected six-log reduction in microorganisms following the disinfection pr... Class II Karl Storz Endoscopy

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.