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.

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Date	Product	Reason	Class	Firm
Jun 14, 2022	Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co...	The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co...	Class III	R & D Systems, Inc.
Jun 9, 2022	Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ...	When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Abl...	Class II	Abbott
May 27, 2022	LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.	There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc...	Class II	Medtronic Neuromodulation
May 25, 2022	EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged a...	Product may be mislabeled.	Class II	Boston Scientific Corporation
May 25, 2022	EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged a...	Product may be mislabeled.	Class II	Boston Scientific Corporation
May 6, 2022	KWIK-STIK" plus: Clostridium perfringens	Labeling error.	Class III	Microbiologics Inc
May 5, 2022	HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As...	Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba...	Class I	Medtronic Inc
May 3, 2022	Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit	The device is unable to meet sterilization requirements when sterilized per instructions in an Ae...	Class II	Tornier, Inc
Apr 28, 2022	FIRMap" Catheter, 60mm Basket	Incorrect product labeling.	Class II	Abbott
Apr 20, 2022	The C304-HIS device features a guide wire to access the vein, a valve to redu...	The firm's internal processes identified that certain lots may have an improperly sealed barrier ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 20, 2022	Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p...	Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.	Class II	Medtronic Perfusion Systems
Apr 18, 2022	Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model...	Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi...	Class I	Smiths Medical ASD Inc.
Apr 18, 2022	Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2...	Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi...	Class I	Smiths Medical ASD Inc.
Apr 14, 2022	HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1...	The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve...	Class I	Medtronic Inc
Apr 12, 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application softw...	Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 12, 2022	Crome Models loaded with CareLink SmartSync Device Manager application softwa...	Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 8, 2022	TMJ Arthroscopy Drape, 85''x 96''	Latex content in product was labeled incorrectly as latex free.	Class II	Microtek Medical Inc.
Mar 30, 2022	Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea...	Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo...	Class II	Medtronic Inc
Mar 30, 2022	Percept BrainSense Implantable Neurostimulator (INS), Model B35200	The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ...	Class II	Medtronic Neuromodulation
Mar 30, 2022	Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200	The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ...	Class II	Medtronic Neuromodulation
Mar 30, 2022	Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap...	The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p...	Class II	Medtronic Neuromodulation
Mar 24, 2022	Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur...	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ...	Class II	Abbott
Mar 24, 2022	Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur...	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ...	Class II	Abbott
Mar 24, 2022	Inactivated macrolide and quinolone-resistant Mycoplasma genitalium	QC process was not adequate for the specification range.	Class II	Microbiologics Inc
Mar 22, 2022	Inactivated macrolide-resistant Mycoplasma genitalium	The QC process was not adequate for the specification range.	Class II	Microbiologics Inc
Mar 21, 2022	WAVES WCM Kidney Cassette Module	There is a potential for the WCM cassette pump head leaking solution.	Class II	Waters Medical Systems LLC
Mar 14, 2022	Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr...	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle...	Class II	Augustine Temperature Management, LLC
Mar 14, 2022	Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr...	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle...	Class II	Augustine Temperature Management, LLC
Mar 14, 2022	Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju...	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle...	Class II	Augustine Temperature Management, LLC
Mar 14, 2022	Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr...	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle...	Class II	Augustine Temperature Management, LLC
Mar 14, 2022	Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr...	HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle...	Class II	Augustine Temperature Management, LLC
Mar 8, 2022	ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support	Pouch seals may be open, compromising sterility.	Class II	Boston Scientific Corporation
Mar 8, 2022	ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy	Pouch seals may be open, compromising sterility.	Class II	Boston Scientific Corporation
Mar 3, 2022	Pneumonia (33 Targets) Control Panel, unassayed quality control material, con...	Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of...	Class II	Microbiologics Inc
Mar 2, 2022	Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar...	There is potential for the capsule bond to break during the procedure.	Class I	Medtronic Inc
Feb 28, 2022	MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo...	There is a software anomaly with the InterStim X Clinician software application with results in t...	Class II	Medtronic Neuromodulation
Feb 25, 2022	Mycoplasma genitalium Control Panel (Inactivated Pellet)	Distributed product did not undergo proper release testing.	Class II	Microbiologics Inc
Feb 17, 2022	Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a co...	Reports have been received that after normal or routine lateral forces are applied to the head fi...	Class II	Deerfield Imaging, Inc.
Feb 4, 2022	Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat...	The device has similarities in design to another device that the firm recently issued a field cor...	Class I	ev3 Inc.
Feb 4, 2022	Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat...	The device has similarities in design to another device that the firm recently issued a field cor...	Class I	ev3 Inc.
Jan 18, 2022	LINQ II Insertable Cardiac Monitor	Devices may lose functionality due to susceptibility to moisture ingress.	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 6, 2021	Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1...	Reports have been received of tip damage during use of the devices which resulted in some instanc...	Class I	ev3 Inc.
Dec 6, 2021	Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1...	Reports have been received of tip damage during use of the devices which resulted in some instanc...	Class I	ev3 Inc.
Nov 22, 2021	WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ...	Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s...	Class I	Cardiovascular Systems Inc
Nov 22, 2021	UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, ...	The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed thro...	Class II	Uromedica Inc.
Nov 19, 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-...	There have been reports of stent migration.	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 16, 2021	Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM	As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was m...	Class II	Abbott
Nov 10, 2021	iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S...	The dosage information on the pouch is incorrect; the primary carton label is correct.	Class III	Tapemark Company
Nov 9, 2021	Amplatzer Steerable Delivery Sheath	Instructions for use were updated.	Class II	Abbott
Nov 9, 2021	Torosa Saline-Filled Testicular Prosthesis (Size Small)	Product is mislabeled for size.	Class II	Coloplast Manufacturing US, LLC

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.