Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 18, 2020 | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | Five IceRod" i-Thaw" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | Due to customer complaints of positive bias impacting quality control. The high and low level co... | Class II | The Binding Site Group, Ltd. |
| Nov 18, 2020 | IceRod" 1.5 PLUS 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... | The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... | Class II | Shimadzu Medical Systems |
| Nov 18, 2020 | IceFORCE" 2.1 CX 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSphere" 1.5 S 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSphere" 1.5 Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSphere" 1.5 CX 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSeed" 1.5 MRI Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSeed" 1.5 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" 1.5 i-Thaw" Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IcePearl" 2.1 CX Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | Five IceSphere" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" 1.5 CX 90¿ Cryoablation Needle¿ | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IcePearl" 2.1 CX 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSeed" 1.5 Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 17, 2020 | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbos... | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU)... | Class II | Zimmer Biomet, Inc. |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 17, 2020 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... | A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 17, 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... | Failure to execute the visual inspection correctly prior to locking the valve during the deployme... | Class I | Boston Scientific Corporation |
| Nov 16, 2020 | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M006... | Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... | Class II | Boston Scientific Corporation |
| Nov 16, 2020 | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... | The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... | Class II | Covidien Llc |
| Nov 16, 2020 | Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M0061801560... | Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... | Class II | Boston Scientific Corporation |
| Nov 16, 2020 | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Ce... | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in ... | Class II | Galt Medical Corporation |
| Nov 15, 2020 | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 13, 2020 | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determinat... | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... | Class II | Randox Laboratories Ltd. |
| Nov 13, 2020 | Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of ... | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... | Class II | Randox Laboratories Ltd. |
| Nov 13, 2020 | Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable car... | There is potential for fractures which results in the inability to delivery therapy. | Class I | Boston Scientific Corporation |
| Nov 12, 2020 | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone ... | The product is mislabeled. | Class II | Biocomposites, Ltd. |
| Nov 12, 2020 | Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compr... | Under certain conditions, there is a risk for fire. | Class II | Hill-Rom Manufacturing, Inc. |
| Nov 12, 2020 | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment... | During internal testing, it was found that upon a device reset, the Generator exhibits the incorr... | Class II | LivaNova USA Inc |
| Nov 12, 2020 | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... | A710 Intellis Clinician Application has a software issue that can result in the inability to prog... | Class II | Medtronic Neuromodulation |
| Nov 12, 2020 | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic pr... | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... | Class II | ConMed Corporation |
| Nov 12, 2020 | Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic pr... | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which c... | Class II | ConMed Corporation |
| Nov 12, 2020 | CareLink Personal Software Therapy Management Software Tool for Diabetes Car... | Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... | Class II | Medtronic Inc. |
| Nov 11, 2020 | Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX ... | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... | Class II | Westmed, Inc. |
| Nov 11, 2020 | RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B... | Two issues were found with the treatment plan report: 1) There may be incorrect information for t... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 11, 2020 | REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Fem... | There is a potential that the fitment between the oxygen delivery tube and the mask adapter may b... | Class II | Westmed, 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.