Browse Device Recalls
4,545 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,545 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 4,545 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001... | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 23, 2025 | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The B... | Due to fingerprint scanner failing resulting in the scanner heating up. | Class II | CareFusion 303, Inc. |
| Jan 23, 2025 | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite ... | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in th... | Class II | CareFusion 303, Inc. |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling around manual access... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... | Labeling update to include a contraindication statement against the use of medicine cabinets in ... | Class II | CareFusion 303, Inc. |
| 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. |
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.