Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
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.
Jun 15, 2020 POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... Class III Access Scientific LLC
Jun 10, 2020 ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:0088687... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
Jun 10, 2020 Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008... The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal sur... Class II NuVasive Inc
Jun 10, 2020 Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:008868741... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
May 21, 2020 VistaSolution, physiological signal transmitter. A software graphical user in... A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the softwa... Class II Vitalconnect Inc.
May 12, 2020 MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 12, 2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 12, 2020 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 6, 2020 Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A... A material weakness adjacent to the polymer fill channel may become compromised during pressuriza... Class I Endologix, Inc.
Apr 30, 2020 MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 30, 2020 MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 30, 2020 MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK... Missing solder battery connection, which could interrupt power of insulin pump. Class II Medtronic Inc.
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max ... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3F... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Exte... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 22, 2020 PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only S... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 22, 2020 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERI... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 10, 2020 Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 045... Internal testing results showed endotoxin-related test result did not meet specifications for im... Class II Medtronic Inc.
Mar 31, 2020 Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... False positive reaction on the reagent. Class II Becton, Dickinson and Company, BD Biosciences
Mar 30, 2020 iQ200 Series Urine Microscopy Analyzer- All part numbers A defect in the SATA power adapter cable within the instrument s computer has the potential risk ... Class II Beckman Coulter Inc.
Mar 30, 2020 iChem¿VELOCITY Urine Chemistry System- A defect in the SATA power adapter cable within the instruments computer has the potential risk f... Class II Beckman Coulter Inc.
Mar 27, 2020 Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFK... Sterile catheter kit packaging compromised. Class II Edwards Lifesciences, LLC
Mar 25, 2020 Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr... Incorrect expiration date Class II Abbott Vascular
Mar 23, 2020 Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Asp... The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of... Class II INARI MEDICAL
Mar 20, 2020 Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm ... The product has an incorrect reference value for cadmium and an incorrect expected range. Class III Utak Laboratories 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.