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 |
|---|---|---|---|---|
| Apr 29, 2021 | Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, ... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion Sy... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion Sy... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 29, 2021 | Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System,... | Specific lots may have been manufactured with insufficient or incomplete welds. | Class II | Medtronic Perfusion Systems |
| Apr 22, 2021 | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 | Potential capacitor failure which typically manifests as in inability to provide output on one or... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| Apr 21, 2021 | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr... | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E... | Class II | Boston Scientific Corporation |
| Apr 20, 2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in c... | The lot may have experienced an anomaly during the manufacturing process, that could lead to an o... | Class II | Medivators, Inc. |
| Apr 12, 2021 | VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of o... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 7, 2021 | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card... | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Programmers - Product Usage: used to treat arrhythmias related to bradycardia... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Mar 31, 2021 | Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and b... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Palm Cups - Product Usage: intended to be used to percuss the chest wall to m... | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during an... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX49... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the d... | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids.... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Mo... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitorin... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Nu... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Left Heart Kit, Model Number M20268. for blood pressure monitoring. | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 31, 2021 | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 12... | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Mede... | Class II | Smiths Medical ASD Inc. |
| Mar 25, 2021 | Intellis Model 97755 Recharger - Product Usage: designed to charge the follow... | There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. | Class II | Medtronic Neuromodulation |
| Mar 23, 2021 | VenaSeal Closure System | Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... | Class III | Medtronic Inc. |
| Mar 16, 2021 | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... | Incorrect size printed on the device; packaging is labeled correctly. | Class II | Medtronic Inc. |
| Mar 9, 2021 | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr... | There are two issues within this correction action: 1. Cycling Issue: When copying settings fro... | Class II | Medtronic Neuromodulation |
| Mar 5, 2021 | MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... | Class II | Boston Scientific Corporation |
| Mar 5, 2021 | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... | Class II | Boston Scientific Corporation |
| Mar 3, 2021 | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... | An electrical component within the system controller module of certain Bio-Console 560 devices ma... | Class I | Medtronic Perfusion Systems |
| Feb 24, 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | Class III | Microbiologics Inc |
| Feb 24, 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | Class III | Microbiologics Inc |
| Feb 4, 2021 | Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reserv... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Card... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Af... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
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.