Browse Device Recalls

288 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 288 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 288 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 16, 2024	COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def...	Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m...	Class II	Medtronic Inc.
Apr 16, 2024	Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def...	Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m...	Class II	Medtronic Inc.
Apr 16, 2024	COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove...	Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m...	Class II	Medtronic Inc.
Apr 16, 2024	COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr...	Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m...	Class II	Medtronic Inc.
Apr 16, 2024	EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib...	Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m...	Class II	Medtronic Inc.
Mar 4, 2024	X-Guide Handpiece Adaptor Sleeve 1, Model P010701	The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g...	Class II	X-NAV Technologies, LLC
Mar 4, 2024	X-Guide Handpiece Adaptor Sleeve 3, Model P010727	The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g...	Class II	X-NAV Technologies, LLC
Jan 9, 2024	Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC	manufacturing defects to sensor cable connectors may result in error codes or non-functioning c...	Class II	Covidien
Jan 9, 2024	Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC	manufacturing defects to sensor cable connectors may result in error codes or non-functioning c...	Class II	Covidien
Dec 18, 2023	PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78...	Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak du...	Class II	Angiodynamics, Inc.
Nov 10, 2023	Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	Medex LOGICAL CATH LAB KIT, List Number M20754	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	6IN PRESSURE TUBING, List Number MX20617	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Oct 19, 2023	Para-Pak Clean Vial-For the collection, transportation, preservation, and exa...	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ...	Class II	Meridian Bioscience Inc
Oct 19, 2023	Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres...	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ...	Class II	Meridian Bioscience Inc
Oct 19, 2023	Cardinal Health Clean Stool Transportation System-For the collection, transpo...	Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.	Class II	Meridian Bioscience Inc
Jul 13, 2023	Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300...	Due to a manufacturing defect of a supplier provided component, there is a potential that the aud...	Class II	ICU Medical Inc
Apr 20, 2023	Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G...	Some catheters had a manufacturing defect where the clear resealing label separating from the pro...	Class II	C.R. Bard Inc
Apr 20, 2023	Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5...	Some catheters had a manufacturing defect where the clear resealing label separating from the pro...	Class II	C.R. Bard Inc
Apr 20, 2023	Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180...	Some catheters had a manufacturing defect where the clear resealing label separating from the pro...	Class II	C.R. Bard Inc
Apr 20, 2023	HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b...	Some catheters had a manufacturing defect where the clear resealing label separating from the pro...	Class II	C.R. Bard Inc
Mar 22, 2023	Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi...	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss...	Class I	ICU Medical Inc
Mar 22, 2023	ASM Replacement Battery, Component Number SUB0000594	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss...	Class I	ICU Medical Inc
Mar 22, 2023	ASM Replacement Battery, Component Number SUB0000864	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss...	Class I	ICU Medical Inc
Mar 22, 2023	Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System...	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss...	Class I	ICU Medical Inc
Nov 18, 2022	Cardinal Health Presource Packs IV START KIT- Intended for IV access device ...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Nov 18, 2022	Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Nov 18, 2022	Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device...	Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i...	Class II	Cardinal Health 200, LLC
Aug 1, 2022	6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	MicroClave Clear Neutral Connector. A bidirectional connector used as an acce...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Aug 1, 2022	6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi...	Due to a manufacturing defect which results in a visible gap between the connector's top and bott...	Class II	ICU Medical, Inc.
Sep 9, 2021	GENOSYL DS (Delivery System) console, for use as a vasodilator.	Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery ...	Class I	Vero Biotech, LLC
May 13, 2021	Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te...	Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a...	Class II	Siemens Healthcare Diagnostics, Inc.
May 13, 2021	Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te...	Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a...	Class II	Siemens Healthcare Diagnostics, Inc.
May 13, 2021	Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t...	Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a...	Class II	Siemens Healthcare Diagnostics, Inc.
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...
Dec 16, 2020	Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Nu...	A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that c...	Class II	Cook Medical Llc
Jul 6, 2020	128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit ...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Rem...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifol...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, 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.