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Vehicle Safety

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
Aug 2, 2021 BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD Sma... Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V... Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing Smart... Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit... Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Aug 2, 2021 BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAM... Needle-free connector valves, either standalone or attached to extension sets, may have issues in... Class II CAREFUSION
Jun 9, 2021 MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product ... A portion of a validation lot was inadvertently released to the US Market. The product did not m... Class II CAREFUSION
Mar 3, 2021 BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module... Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module contin... Class I CareFusion 303, Inc.
Aug 4, 2020 PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ... The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari... The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, ... Infusion pump component defect may result in interruption of patient monitoring Class II CareFusion 303, Inc.
Aug 4, 2020 Alaris System PC Unit Model 8015 The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assemb... Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress p... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained ... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide traine... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8000 modular infusion pump and monitoring system If one or more screws or washers are loose or missing causing the battery not to be properly secu... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to ... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and mon... Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris Pump Module Model 8100 Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trai... LED display, which provides infusion or patient monitoring values, on the module may have segment... Class II CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8015. modular infusion pump and monitoring system If one or more screws or washers are loose or missing causing the battery not to be properly secu... Class I CareFusion 303, Inc.
Jun 30, 2020 Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... Class I CareFusion 303, Inc.
May 28, 2020 Thora-Para 5 Fr Non-Valved Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection ... The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection ... The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Thora-Para 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T-Centesis 6 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T-Centesis 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Thora-Para 5 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 28, 2020 Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... Class II Carefusion 2200 Inc
May 18, 2020 Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical bl... Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handl... Class II Carefusion 2200 Inc
Mar 26, 2020 CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use On... The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. Class II Becton Dickinson & Company
Feb 4, 2020 CareFusion Alaris Syringe Module, Model 8110 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Feb 4, 2020 CareFusion Alaris Pump Module, Model 8100 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, 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.