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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
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock P... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Dr... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Feb 25, 2016 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... Class II ICU Medical, Inc.
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext S... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore T... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotati... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Aug 19, 2014 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, 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.

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.