Browse Device Recalls

3,435 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,435 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 3,435 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Jan 29, 2020	NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 29, 2020	NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00...	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.	Class I	Abbott Vascular
Jan 23, 2020	HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System...	Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA...	Class I	Heartware, Inc.
Jan 23, 2020	HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica...	Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA...	Class I	Heartware, Inc.
Jan 7, 2020	CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG ...	Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster ...	Class I	CME America, LLC
Dec 13, 2019	HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit	There is the potential for water to flood the column and enter the circuit under circumstances wh...	Class I	TELEFLEX MEDICAL INC
Dec 13, 2019	HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier...	There is the potential for water to flood the column and enter the circuit under circumstances wh...	Class I	TELEFLEX MEDICAL INC
Dec 13, 2019	HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, RE...	There is the potential for water to flood the column and enter the circuit under circumstances wh...	Class I	TELEFLEX MEDICAL INC
Dec 13, 2019	HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperatu...	There is the potential for water to flood the column and enter the circuit under circumstances wh...	Class I	TELEFLEX MEDICAL INC
Dec 12, 2019	ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150	Combination of software and a component failure may cause audible alarms not to operate properly,...	Class I	ResMed Ltd.
Dec 4, 2019	0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Dec 4, 2019	0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Nov 25, 2019	Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended...	GE Healthcare has become aware that there is a potential for a loose cable connection inside spec...	Class I	GE Healthcare, LLC
Nov 25, 2019	Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended...	GE Healthcare has become aware that there is a potential for a loose cable connection inside spec...	Class I	GE Healthcare, LLC
Nov 21, 2019	Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 21, 2019	Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-...	There have been reported incidents of a loose reservoir that can no longer be locked into the pum...	Class I	Medtronic Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 15, 2019	PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende...	A defect involving an occluded needle was discovered during a training exercise.	Class I	Tytek Medical Inc
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 8, 2019	CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ...	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 Cro...	Class I	Cook Inc.
Nov 5, 2019	King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visuali...	Exhibiting a reversed image. Although the image may appear normal, the users actions will be reve...	Class I	King Systems Corp. dba Ambu, Inc.
Oct 28, 2019	Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei...	There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ...	Class I	Smiths Medical ASD Inc.
Oct 24, 2019	Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 24, 2019	Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 24, 2019	Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 11, 2019	Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer	Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio...	Class I	GE Healthcare, LLC
Oct 11, 2019	Synchromed II programmable pump, Model numbers 8637-20 and 8637-40	There is a potential for the presence of a foreign particle inside the pump motor assembly which ...	Class I	Medtronic Neuromodulation
Oct 11, 2019	Giraffe OmniBed infant warmer	Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio...	Class I	GE Healthcare, LLC
Oct 11, 2019	Giraffe Incubator infant warmer	Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio...	Class I	GE Healthcare, 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.