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.

DateProductReasonClassFirm
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.