Browse Device Recalls

1,624 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,624 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 1,624 FDA device recalls in MN.

Clear

Date	Product	Reason	Class	Firm
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
Feb 3, 2021	Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,...	A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 3, 2021	Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ...	A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 22, 2021	ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U...	Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section...	Class I	Acist Medical Systems
Jan 20, 2021	Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR imm...	R&D Systems, Inc. received two complaints that the standard signal was low and controls were not ...	Class II	R & D Systems, Inc.
Jan 18, 2021	Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend...	Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless Fle...	Class II	Smiths Medical ASD Inc.
Jan 11, 2021	Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product...	Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. ...	Class II	Ecolab Inc
Dec 21, 2020	Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use...	Shipping box may contain wrong model.	Class II	Smiths Medical ASD Inc.
Dec 16, 2020	KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ...	Contamination with S. epidermidis	Class II	Microbiologics Inc
Dec 16, 2020	KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte...	The expiration date on the label of one component (negative control 0243U) in the set lot is inco...	Class III	Microbiologics Inc
Dec 15, 2020	ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate g...	Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that d...	Class II	Boston Scientific Corporation
Dec 15, 2020	PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60P...	A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incor...	Class II	Smiths Medical ASD Inc.
Dec 8, 2020	smiths medical portex Loss of Resistance Device, REF 100/398/000	The labeling was missing information on sterilization and prohibition of reuse.	Class II	Smiths Medical ASD Inc.
Dec 2, 2020	EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM MRI S-ICD Model A219	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 2, 2020	EMBLEM S-ICD Model A209	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Nov 23, 2020	LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immun...	Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient s...	Class II	Diasorin Inc.
Nov 19, 2020	Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ...	A software anomaly in the A620 Patient Programmer application was identified that results in fail...	Class II	Medtronic Neuromodulation
Nov 18, 2020	IceSphere" 1.5 90¿ Cryoablation Needle	Complaint trend regarding needle shaft gas leaks.	Class II	Boston Scientific Corporation
Nov 18, 2020	IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿	Complaint trend regarding needle shaft gas leaks.	Class II	Boston Scientific Corporation
Nov 18, 2020	IcePearl" 2.1 CX Prostate Cryoablation Kit	Complaint trend regarding needle shaft gas leaks.	Class II	Boston Scientific Corporation
Nov 18, 2020	IceRod" 1.5 MRI 90¿ Cryoablation Needle¿	Complaint trend regarding needle shaft gas leaks.	Class II	Boston Scientific Corporation

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.