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Browse Device Recalls

164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 164 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 164 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
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.
Nov 17, 2017 Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II CareFusion 303, Inc.
Nov 6, 2017 Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used... Reports of incorrect priming volume due to manufacturing with incorrect tubing. Class II CareFusion 303, Inc.
Aug 9, 2017 Alaris Pump Module model 8100 manufactured between November 2011 and March 20... The recalling firm has received reports of increased or decreased flows that have occurred in cer... Class II CareFusion 303, Inc.
Jun 30, 2017 VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used... Punctures in blister packaging that was detected during the packaging process. Class II CareFusion 303, Inc.
Jun 12, 2017 Alaris PC Unit, Model 8015 BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios whi... Class II CareFusion 303, Inc.
Jun 12, 2017 Alaris Pump Module model 8100 There is a potential risk that could cause unintended flow in the older, centered sear door latch... Class II CareFusion 303, Inc.
Feb 20, 2017 MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGu... CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.... Class II CareFusion 303, Inc.
Feb 20, 2017 MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. M... CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter beca... Class II CareFusion 303, Inc.
Dec 2, 2016 Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/... During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. Class I CareFusion 303, Inc.
Nov 17, 2016 SmartSite Add-On Bag Access Device, Model No. 10013365 CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leaka... Class II CareFusion 303, Inc.
Nov 1, 2016 Alaris System PC unit, model no. 8000 and 8015. The central programming, mon... Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered bef... Class II CareFusion 303, Inc.
Aug 8, 2016 Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syr... A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to ... Class II CareFusion 303, Inc.
May 12, 2016 Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr... A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea... Class II CareFusion 303, Inc.
Mar 24, 2016 Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, ... The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the s... Class II CareFusion 303, Inc.
Feb 15, 2016 Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages a... Class II CareFusion 303, Inc.
Feb 12, 2016 Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca... Class II CareFusion 303, Inc.
Jan 15, 2016 Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... Customers reported issues when scanning medications with the scanners. When a user scans a medic... Class II CareFusion 303, Inc.
Nov 12, 2015 Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end... CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during... Class II CareFusion 303, Inc.
Nov 5, 2015 Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administe... CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection a... Class II CareFusion 303, Inc.
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.
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.
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.

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.