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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

Consumer Safety

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

360 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 360 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 360 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2015 SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic... CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. Class II CareFusion 303, Inc.
Jul 21, 2015 Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect... Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring... Class I CareFusion 303, Inc.
May 13, 2015 Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... An issue with the cancel functionality used during atypical infusion programming to cancel user i... Class II CareFusion 303, Inc.
Apr 3, 2015 CareFusion AVEA ventilator, all models. Product Usage: A continuous venti... A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occl... Class I Carefusion 211 Inc dba Carefusion
Mar 13, 2015 CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Mar 13, 2015 Introduction Pack. A device inserted into an endotracheal tube to aid in the... Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... Class II Vital Signs Colorado Inc.
Mar 12, 2015 Alaris PC units, Model No. 8015. Infusion pump. CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur up... Class II CareFusion 303, Inc.
Jan 13, 2015 SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio... CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i... Class II CareFusion 303, Inc.
Sep 8, 2014 Lock nuts for titanium traction tongs are used in traction skull tongs for tr... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Hudson braces are bone cutting and drilling instruments that are used without... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Replacement screw non-springloaded traction tongs are skull tongs for tractio... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Traction tong replacement screws, non-springloaded are used in traction skull... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Manual trephines are bone cutting and drilling instruments that are used with... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 An external vein stripper is an extravascular device used to remove a section... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 A trocar is a sharp-pointed instrument used with a cannula for piercing a ves... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Hudson burrs are bone cutting and drilling instruments that are used without ... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Galt trephines are bone cutting and drilling instruments that are used withou... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Titanium fixation screws, springloaded are used in traction skull tongs for t... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 CVB distraction screws are bone cutting and drilling instruments that are use... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Cushing perforating drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Cloward Spanner gauges are bone cutting and drilling instruments that are use... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Gardner-Wells wrenches are used in traction skull tongs for traction used to ... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 McKenzie Perforator Drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 An endometrial suction curette is a device used to remove material from the u... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 A circumcision clamp is an instrument used to compress the foreskin of the pe... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 A uterine tenaculum is a hook-like instrument used to seize and hold the cerv... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Gardner-Wells traction tongs are skull tongs for traction used to immobilize ... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 McKenzie enlarging burrs are bone cutting and drilling instruments that are u... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 D'errico perforator drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Aug 8, 2014 CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... Class I CareFusion 203, Inc.
Jul 31, 2014 CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira... The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp... Class II Carefusion 2200 Inc
Jun 17, 2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 1006... CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a... Class II CareFusion 303, Inc.
Apr 23, 2014 Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... Class I CareFusion 303, Inc.
Mar 19, 2014 SmartSite Extension Set, Model No. 20029E, intravascular administration set. Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. Class II CareFusion 303, Inc.
Jan 22, 2014 SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless ... CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connec... Class II CareFusion 303, Inc.
Jan 16, 2014 Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, mod... CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they m... Class II CareFusion 303, Inc.
Dec 5, 2013 Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto... CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will... Class I CareFusion 303, Inc.
Nov 8, 2013 SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 243... CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer becau... Class II CareFusion 303, Inc.
Nov 8, 2013 VersaSafe Extension Set, Model No. 21000M-007 CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may ... Class II CareFusion 303, Inc.
Sep 5, 2013 Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ... Class I Carefusion 211 Inc dba Carefusion
Aug 30, 2013 CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... Class II CareFusion 303, Inc.
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 1301631... Class II CareFusion 303, Inc.
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administr... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is... Class II CareFusion 303, Inc.
Aug 28, 2013 *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareF... Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, p... Class II Carefusion 2200 Inc
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Apr 22, 2013 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) ... CareFusion has received four (4) customer reports of a component (oxygen connector) within the re... Class II Carefusion 2200 Inc
Apr 12, 2013 Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
Apr 12, 2013 Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... Class III Covidien LLC
Mar 6, 2013 Alaris PC unit model 8015 with software version 9.12 Product Usage: The... The recall was initiated because Carefusion has identified potential risk associated with bolus p... Class II Carefusion Corporation
Mar 6, 2013 Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... The recall was initiated because Carefusion has received reports of a communication error on the ... Class I Carefusion Corporation

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.