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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.