Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Sep 19, 2019	Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX...	Fetal transducers distributed in advance of receiving 510(k) and international clearances.	Class II	Pacific Medical Group Inc.
Sep 19, 2019	Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgi...	The sterile barrier of some devices may have been affected	Class II	Xodus Medical Inc
Sep 19, 2019	Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX,...	Fetal transducers distributed in advance of receiving 510(k) and international clearances.	Class II	Pacific Medical Group Inc.
Sep 19, 2019	TherMax Blood Warmer Unit	TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires...	Class II	Baxter Healthcare Corporation
Sep 19, 2019	Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory	The sterile barrier of some devices may have been affected	Class II	Xodus Medical Inc
Sep 19, 2019	Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical a...	The sterile barrier of some devices may have been affected	Class II	Xodus Medical Inc
Sep 18, 2019	Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor	Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor ...	Class II	Senseonics, Inc.
Sep 18, 2019	Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.	The metal cannula of the device either broke and the broken piece left in the blood specimen tube...	Class III	Biomedical Polymers, Inc.
Sep 18, 2019	Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T7...	GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser...	Class II	GN Hearing A/S
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood...	The metal cannula of the device either broke and the broken piece left in the blood specimen tube...	Class III	Biomedical Polymers, Inc.
Sep 18, 2019	XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p...	Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.	Class II	Medline Industries Inc
Sep 18, 2019	In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP...	GN Hearing received reports from our manufacturing site in US regarding a software bug in our ser...	Class II	GN Hearing A/S
Sep 18, 2019	iLab Polaris Multi-Modality Guidance System; iLab Ultraso...	Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc...	Class II	Boston Scientific Corporation
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following produ...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 17, 2019	Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Pr...	Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip ...	Class II	Cook Inc.
Sep 16, 2019	Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A060...	Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis...	Class II	Medicrea International
Sep 16, 2019	KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that...	If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the u...	Class II	KT Health, LLC
Sep 16, 2019	Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A0...	Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis...	Class II	Medicrea International
Sep 16, 2019	Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution	Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop...	Class II	Abbott Gmbh & Co. KG
Sep 16, 2019	Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 fo...	The subject product measures 4.0mm in diameter instead of 3.5mm.	Class II	Synthes (USA) Products LLC
Sep 16, 2019	Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC1...	There is a potential performance issue as detected by an under-recovery of sample results during ...	Class II	Axis-Shield Diagnostics, Ltd.
Sep 16, 2019	CardioLab/ComboLab Recording Systems	Potential for failure of the patient leakage current test. There is a potential that if another d...	Class II	GE Healthcare, LLC
Sep 16, 2019	SAROS Oxygen System Model 3000	There is an electronics control issue that causes the unit to not power on with battery power only.	Class II	Caire, Inc.
Sep 16, 2019	Alinity ci Level Sensor, Bulk Solution	Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop...	Class II	Abbott Gmbh & Co. KG
Sep 16, 2019	Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution	Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop...	Class II	Abbott Gmbh & Co. KG
Sep 16, 2019	13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741...	A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.	Class II	Becton Dickinson & Company
Sep 16, 2019	IceCure Cryoablation System ProSense -Intended for cryogenic destruction of t...	Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical...	Class II	Icecure Medical Ltd
Sep 16, 2019	Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR...	There is a potential performance issue as detected by an under-recovery of sample results during ...	Class II	Axis-Shield Diagnostics, Ltd.
Sep 16, 2019	Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR...	There is a potential performance issue as detected by an under-recovery of sample results during ...	Class II	Axis-Shield Diagnostics, Ltd.
Sep 16, 2019	BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Pr...	When using a specific tubing set with infusion pump system, may result in under deliver of fluids.	Class I	CME America, LLC
Sep 13, 2019	The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone...	Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose c...	Class II	Draegar Medical Systems, Inc.
Sep 12, 2019	Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replaceme...	Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le...	Class II	Stryker Corporation
Sep 12, 2019	Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is t...	labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the in...	Class II	Merit Medical Systems, Inc.
Sep 12, 2019	Cerelink ICP Monitor, Model Number 826820; intended for use as an interface ...	There is a potential for a progressive decline in observed ICP readings of the monitor during use.	Class II	Integra LifeSciences Corp.
Sep 12, 2019	Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Pr...	Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-ha...	Class II	Olympus Corporation of the Americas
Sep 12, 2019	Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replaceme...	Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le...	Class II	Stryker Corporation
Sep 12, 2019	CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220,...	Individual packages of connectors may have incomplete or bad seals which would compromise sterility.	Class II	Codan US Corporation
Sep 11, 2019	Respironics V680 Ventilator, Service # 850011, (OUS Only)	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ...	Class II	Respironics California, LLC
Sep 11, 2019	Ultrasound Transducer (M2736A), that may have been serviced with the followin...	Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com...	Class II	Pacific Medical Group Inc.
Sep 11, 2019	Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have be...	Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com...	Class II	Pacific Medical Group Inc.
Sep 11, 2019	Toco+ transducer with ECG/IUP capability (wired), that may have been serviced...	Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com...	Class II	Pacific Medical Group Inc.
Sep 11, 2019	Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 45...	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ...	Class II	Respironics California, LLC
Sep 11, 2019	External Toco Transducer (M1355A), that may have been serviced with the follo...	Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com...	Class II	Pacific Medical Group Inc.
Sep 11, 2019	Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP...	Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ...	Class II	Respironics California, LLC
Sep 11, 2019	OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended f...	Stems missing porous coating on the device.	Class II	OMNIlife science 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.