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Browse Device Recalls

590 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 590 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 590 FDA device recalls.

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DateProductReasonClassFirm
Aug 31, 2020 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
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.
Jul 6, 2020 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Fil... 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 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way S... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 5... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 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 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit pe... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 ... 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 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 p... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 un... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/M... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port ... 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.