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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

309 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 309 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 309 FDA device recalls.

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DateProductReasonClassFirm
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.
Jul 6, 2020 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, Na... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)108406... 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 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave M... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UD... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, Micro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clam... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Co... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per po... 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/3-Port NanoClave Manifold, Check Valve. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, Nano... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, N... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spi... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT Nano... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroCla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, Nan... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 un... 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 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Ma... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector,... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 po... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoCla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 u... 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.