Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Dec 30, 2013 Neptune 2 Rover Ultra Waste Management System The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... Class II Stryker Instruments Div. of Stryker Corporation
Dec 30, 2013 Neptune 2 Rover Ultra Waste Management System. The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... Class II Stryker Instruments Div. of Stryker Corporation
Dec 27, 2013 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARES... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Dec 27, 2013 The Gaymar Medi-Therm device provides a means of regulating patient temperatu... Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water tem... Class II Stryker Medical Division of Stryker Corporation
Dec 26, 2013 KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by... Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software ... Class II Carestream Health, Inc.
Dec 26, 2013 Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use... A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit a... Class II Vital Signs Colorado Inc.
Dec 24, 2013 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCl... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron F... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating L... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Nee... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rot... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connect... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave",... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoC... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Lue... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv C... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClav... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rota... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, P... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoCl... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClav... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syp... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Par... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Co... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings)... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... 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.