Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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DateProductReasonClassFirm
Jul 12, 2024 Ion Endoluminal System, REF: 380748-65 There is a potential that the robotic system's instrument cart arm may contain screws that may ... Class II Intuitive Surgical, Inc.
Jul 9, 2024 BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 9, 2024 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jul 1, 2024 Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. Class II Neurovision Medical Products Inc
Jun 25, 2024 HeartMate 3 System Controllers provided within the following HeartMate 3 Left... Left ventricular assist system controller UI membrane/screen may lift along the edge of the contr... Class II Thoratec LLC
Jun 25, 2024 Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... Class II Preat Corp
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... Any single affected ventilator should only be used for the 10- year labelled service life, but if... Class I Covidien
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software versio... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software ver... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software versio... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version ... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software ver... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version ... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software ver... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 24, 2024 BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, Inc.
Jun 20, 2024 Cepheid, Sample Collection Device, Part: 900-0370 Specimen collection device may leak after the patient sample swabs have been inserted into the te... Class II Cepheid
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
Jun 7, 2024 OMTech Desktop Laser Engraver Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... Class II Rygel Advanced Machines d/b/a Omtech Laser
Jun 4, 2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... Insufficient weld around the cap component of the instrument is insufficient to withstand impact... Class II SEASPINE ORTHOPEDICS CORPORATION
Jun 3, 2024 Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve... Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of t... Class II Nalu Medical, Inc.
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 LIH Influence check settings for Lipemia are incorrect which may result patient samples being rep... Class II Beckman Coulter Inc.
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Soft... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 24, 2024 Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COV... Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Autho... Class II CUE HEALTH INC
May 21, 2024 BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Due to a software issue the PC unit may not connect to the server which could impact wireless dat... Class II CareFusion 303, Inc.
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... Class II SEASPINE ORTHOPEDICS CORPORATION
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... Class II SEASPINE ORTHOPEDICS CORPORATION
May 13, 2024 BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN ... Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... Class II CareFusion 303, Inc.
May 13, 2024 BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH ME... Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... Class II CareFusion 303, Inc.
May 10, 2024 MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-... The terminal block used to secure the power supply cable for the gradient coil of the MRI system ... Class II Canon Medical System, USA, INC.
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... Class I Thoratec Corp.
May 8, 2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... Multitest with compromised raw material used to assess immune system status may result in flow cy... Class II Becton, Dickinson and Company, BD Biosciences
May 6, 2024 NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
May 6, 2024 NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
May 3, 2024 Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting ... Class II Channel Medsystems, Inc.
May 2, 2024 BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; An... If automated dispensing cabinets have specific software versions, and Component Manager was confi... Class II CareFusion 303, Inc.
Apr 30, 2024 TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 ... A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a fe... Class II Outset Medical, Inc.
Apr 29, 2024 BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... Due to software issue the device may give false "SpO2 Probe Failure" alarm Class II Nihon Kohden America 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.