Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Class II | Randox Laboratories, Limited |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in... | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power a... | Class I | Max Mobility LLC |
| Dec 20, 2024 | ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Dec 20, 2024 | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| 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 | 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. |
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.