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Browse Device Recalls

352 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 352 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 352 FDA device recalls.

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DateProductReasonClassFirm
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.
Feb 4, 2020 CareFusion Alaris PCA Module, Model 8120 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 System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... Class I CareFusion 303, Inc.
Jul 1, 2019 Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 1163456... Calibration; it has been determined that the capnographs may have been calibrated during manufact... Class II CareFusion 303, Inc.
May 10, 2019 Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L... Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata... Class I Teleflex Medical
May 2, 2019 CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displace... After disconnection of a luer, the valve of the connector remains recessed; not fully closing, ei... Class II Becton Dickinson & Company
Apr 20, 2018 Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... Complaints where users were unable to prime the administration set. Class II CareFusion 303, Inc.
Apr 13, 2018 Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with F... The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bez... Class I CareFusion 303, Inc.
Nov 17, 2017 Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II 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.