Browse Device Recalls
780 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 780 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 780 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2024 | Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered in... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 13, 2024 | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizo... | Non-conformance pertains to electromagnetic compatibility requirements according to the internati... | Class II | Hologic Inc |
| May 17, 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | Electroneurodiagnostic medical device may contain a defective printed circuit board which may ca... | Class II | Cadwell Industries Inc |
| May 16, 2024 | Inspire Model 3028, IV Implantable Pulse Generator | There is a potential manufacturing defect which can lead to electrical leakage in the sensing cir... | Class I | Inspire Medical Systems Inc. |
| May 13, 2024 | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power... | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standa... | Class II | Draeger Medical Systems, Inc. |
| 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 9, 2024 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... | Class II | Remote Diagnostic Technologies Ltd. |
| 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 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems i... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical System... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indi... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
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.