Browse Device Recalls
1,677 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,677 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 1,677 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 4, 2017 | Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM... | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... | Class II | Smiths Medical ASD Inc. |
| Dec 4, 2017 | PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM... | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kit... | Class II | Smiths Medical ASD Inc. |
| Nov 29, 2017 | BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065... | Some printing modes on the devices may not function properly (tabular data printing, real-time co... | Class II | Smiths Medical ASD Inc. |
| Nov 22, 2017 | ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905... | The incorrect IFU was shipped with the product. | Class III | ECOLAB INC |
| Nov 22, 2017 | ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906,... | The incorrect IFU was shipped with the product. | Class III | ECOLAB INC |
| Nov 22, 2017 | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... | Class II | Smiths Medical ASD Inc. |
| Nov 14, 2017 | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and in... | Due to a software error, it was observed that when the user closes the access door, the system wi... | Class II | Carl Zeiss Metrology Inc |
| Nov 13, 2017 | Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps a... | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... | Class II | Smiths Medical ASD Inc. |
| Nov 13, 2017 | Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps a... | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... | Class II | Smiths Medical ASD Inc. |
| Nov 13, 2017 | Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps a... | Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misi... | Class II | Smiths Medical ASD Inc. |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Nov 3, 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... | Stent length on the label may not match the length of the stent itself. | Class II | Medtronic Inc. |
| Nov 1, 2017 | ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014... | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergi... | Class II | 3M Company - Health Care Business |
| Oct 17, 2017 | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors... | During a recent investigation, 3M confirmed that a programming translation error could occur in a... | Class II | 3M Company - Health Care Business |
| Oct 13, 2017 | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. | Class II | Ecolab, Inc. |
| Oct 5, 2017 | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. | The firm received complaints that involved an unanticipated interaction between a NeuroBlate syst... | Class I | Monteris Medical Corp |
| Oct 4, 2017 | VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therap... | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE EL ICD DR, Model D433, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | MOMENTUM X4 CRT-D, Model G138, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE EL ICD VR, Model D432, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Oct 4, 2017 | RESONATE X4 CRT-D, Model G447, Sterile. | The devices have an incorrect firmware configuration. | Class II | Boston Scientific Corporation |
| Sep 26, 2017 | 6F Taiga Guiding Catheter | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | Class I | Medtronic Inc |
| Sep 25, 2017 | CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. No... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 25, 2017 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented ... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 25, 2017 | CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvente... | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may... | Class II | Smiths Medical ASD Inc. |
| Sep 21, 2017 | Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692... | There is a possibility that specific lots of catheters that have recently been distributed may be... | Class III | Medtronic Neuromodulation |
| Sep 15, 2017 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b... | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i... | Class II | HILL-ROM MANUFACTURING, INC. |
| Sep 14, 2017 | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... | Class II | Cardiovascular Systems Inc |
| Sep 14, 2017 | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... | Class II | Cardiovascular Systems Inc |
| Aug 24, 2017 | Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient contr... | In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not matc... | Class II | Smiths Medical ASD Inc. |
| Aug 23, 2017 | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system.... | It was discovered a low-level radiation leak that was found on the NSI X-7000 system. | Class II | North Star Imaging Inc |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2017 | UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/08... | Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy T... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2017 | IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw | incorrect thread on thumbscrews | Class II | Deerfield Imaging |
| Aug 9, 2017 | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ... | Medtronic implemented a final design change intended to address the motor stall due to corrosion ... | Class II | Medtronic Neuromodulation |
| Jul 28, 2017 | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc.... | Needle Bond may not be able to withstand the tension force applied when the shaped needle is depl... | Class II | NXTHERA |
| Jul 14, 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Med... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jun 29, 2017 | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 29, 2017 | SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... | The device can deliver an atypical amount of energy due to memory corruption inside the device. | Class II | Boston Scientific Corporation |
| Jun 22, 2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 14, 2017 | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Ma... | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of th... | Class II | Medspira, Llc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenz... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics 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.