Browse Device Recalls

150 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 150 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 150 FDA device recalls.

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DateProductReasonClassFirm
Jan 28, 2025 Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00... The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Jan 28, 2025 Optima XR646 HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... Class II GE Medical Systems, LLC
Dec 6, 2024 Portrait Core Services, a set of software services that enable the communicat... There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 25, 2024 GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numb... GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-0... Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Nov 18, 2024 Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... Class II GE Medical Systems, LLC
Oct 28, 2024 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 SIGNA Architect, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 Discovery MR750w 3.0T, whole body magnetic resonance scanner Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
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 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
Nov 16, 2022 B125M Patient Monitor, REF 6160000-005-XXXXXXX GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B105M Patient Monitor, REF 6160000-003 GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B125P Patient Monitor (with E-module slot option), REF 6160000-002 GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B125M Patient Monitor, REF 6160000-004-XXXXXX GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 10, 2022 Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging ... Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... Class II GE Medical Systems, LLC
Nov 10, 2022 Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging... Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... Class II GE Medical Systems, LLC
Nov 10, 2022 Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imagin... Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... Class II GE Medical Systems, LLC
Nov 10, 2022 Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obs... Potential for batteries that have not been replaced at 2 years, as recommended in the Service Man... Class II GE Medical Systems, LLC

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.