Browse Device Recalls
1,646 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,646 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 1,646 FDA device recalls in MN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 7, 2017 | ESSENTIO EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VALITUDE X4 CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO MRI EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO MRI SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ALTRUA 2 SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VALITUDE CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE MRI EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ALTRUA 2 EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ESSENTIO DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | VISIONIST CRT-P Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | ACCOLADE DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| Dec 7, 2017 | PROPONENT SR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... | Class II | Boston Scientific Corporation |
| 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. |
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.