Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA... | During the assembly of the cartridge to its connecting body part, the valve may open prematurely ... | Class II | New Medical Technologies Gmbh |
| 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 | Bodor P and C series laser cutting machines | Non-compliant laser products | Class II | Jinan Bodor Cnc Machine Co Ltd |
| 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 | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... | The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... | Class II | Ortho-Clinical Diagnostics, 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 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... | Class II | Ortho-Clinical Diagnostics, 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 | BD PCR Cartridges used with MAX System. Model Number: 437519 | Potential for signal drift in specific lots of BD PCR Cartridges. | Class II | Becton Dickinson & Co. |
| 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. |
| 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 | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-... | During the assembly of the cartridge to its connecting body part, the valve may open prematurely ... | Class II | New Medical Technologies Gmbh |
| 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 |
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.