Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Jan 8, 2025 (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... Software issues could potentially result in: 1) delays in accessing dispensing software applicati... Class II CareFusion 303, Inc.
Jan 8, 2025 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... Class II Hologic, Inc.
Jan 5, 2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Cathe... Due to an observed trend of neurovascular events Class I Biosense Webster, Inc.
Jan 2, 2025 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... Identified reagent lots are experiencing a high rate of calibration failures with failure code of... Class II Beckman Coulter Inc.
Dec 28, 2024 NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-... Due to nasal spray stability failure for bioburden. Class II Neilmed Pharmaceuticals Inc
Dec 19, 2024 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,COBRA GRASPER,IS4000 REF 471190 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM, POTTS SCISSORS, IS4000 REF 470001 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,FORCE BIPOLAR,IS4000 REF 470405 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi S... Due to an increase in complaints for pitch cable failures related to forceps and small Graptor in... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,FORCE BIPOLAR,IS4000 REF 471405 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with... Due to an increase in complaints for pitch cable failures related to forceps and small Graptor in... Class II Intuitive Surgical, Inc.
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 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 REF 471049 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
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 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.

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.