Browse Device Recalls
38,658 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,658 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 38,658 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 10, 2025 | IDM-MULTI-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | All-round Joystick R-net Light. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-ARLITE-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | Micro Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nuc... | FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures w... | Class II | Biofire Defense |
| Jul 10, 2025 | Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... | Reports of delayed access to medication in automated dispensing cabinets because of the override/... | Class III | CareFusion 303, Inc. |
| Jul 10, 2025 | IDM-MICRO-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 9, 2025 | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 9, 2025 | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... | Label is incorrect. The product label indicates that the device contains an air eliminating filte... | Class I | B BRAUN MEDICAL INC |
| Jul 9, 2025 | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C... | Potential for the manometer port being blocked rendering the manometer non-functional. | Class I | Ambu Inc. |
| Jul 9, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Encore Medical, LP |
| Jul 9, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Encore Medical, LP |
| Jul 8, 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B... | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 340335 | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb... | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, ... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 8, 2025 | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 8, 2025 | The Medline General Surgery Tray is customized to meet requirements of the ho... | Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s... | Certain batches are being removed due to an increase in complaints received in which physicians e... | Class I | Boston Scientific Corporation |
| Jul 7, 2025 | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some e... | Class II | Siemens Healthcare Diagnostics Inc |
| Jul 3, 2025 | X3-1 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | S7-2t Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | S12-4 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | S8-3 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C9-5ec Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | C10-3v Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L17-5 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes configured with Phantom Frames | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | X7-2t Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L15-7IO TRANSDUCER Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C5-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | D2TCD Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes with Dragonfly frames | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | OMNI III TEE Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L11-3 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C9-3io Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | X8-2t Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | XL14-3 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | V9-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L12-5 50 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C9-4 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | V6-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | c5-1 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L12-3 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | S5-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L12-4 Lumify Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | X5-1c Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L15-7io Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, 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.