Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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DateProductReasonClassFirm
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 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 17, 2024 Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Prod... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... Class I Megadyne Medical Products, Inc.
Jun 17, 2024 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGA... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... Class I Megadyne Medical Products, Inc.
Jun 17, 2024 Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product N... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... Class I Megadyne Medical Products, Inc.
Jun 14, 2024 Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.
Jun 3, 2024 QIAcube Connect MDx - IVD Instrument designed to perform automated isolation ... Heater shaker module does not perform heating if the temperature is set below 40¿C for static inc... Class II Qiagen Sciences LLC
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 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 23, 2024 Surgical Image Guidance Functionality, software used with NGENUITY 3D Visuali... After surgery initiation, while using surgical image guidance, if significant eye rotation/moveme... Class II Alcon Research LLC
May 22, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoas... Class II Beckman Coulter, 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.