Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2024 | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Rad... | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. | Class II | Reflexion Medical, Inc. |
| Apr 16, 2024 | PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defib... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardi... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Product not distributed in the US. Implantable Cardioverter Defibrillators: ... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardiover... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Stryker Blueprint Software, Catalog #BPUE001. | The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented impla... | Class II | Tornier S.A.S. |
| Apr 16, 2024 | MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 16, 2024 | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib... | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... | Class II | Medtronic Inc. |
| Apr 15, 2024 | BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Apr 15, 2024 | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H39... | There is a potential issue regarding the service handles for the internal lead (Pb) covers in tha... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Apr 15, 2024 | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal... | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple li... | Class II | Covidien, LP |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Apr 15, 2024 | BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | BD Pyxis MedStation ES, REF: 323, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis" Anesthesia Station ES, REF: 327 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | BD Pyxis(TM) Anesthesia Station 4000, REF: 338 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... | Class II | Stryker Orthopaedics |
| Apr 15, 2024 | CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. | The firm identified that the measured patient leakage current in some devices significantly excee... | Class II | Maquet Medical Systems USA |
| Apr 12, 2024 | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used w... | Screw is 16mm long instead of 22mm long. | Class II | Medartis Inc. |
| Apr 11, 2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 11, 2024 | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that ut... | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting caus... | Class II | Securitas Healthcare LLC |
| Apr 11, 2024 | FDR Visionary Suite - Intended to generate digital or conventional radiograph... | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, co... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 10, 2024 | 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too b... | Due to incorrect milled titanium abutment being packaged and labeled. | Class II | Preat Corp |
| Apr 10, 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent leve... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantita... | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Apr 9, 2024 | Spectrum IQ Infusion pump, Product Code 357009 | There is a potential for cracks on the mount of the front panel of the device. | Class II | Baxter Healthcare Corporation |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Fre... | Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Apr 9, 2024 | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON... | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | Class II | GE Medical Systems Information Technologies Inc |
| Apr 9, 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... | Class II | Sophysa S.A. |
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.