Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... | Class II | Luminex Molecular Diagnostics Inc |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 3, 2024 | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Aug 29, 2024 | Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum... | Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact... | Class II | Microcare Medical |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 19, 2024 | IntelliSystem Inflation Device, REF: IN1525/D | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | StabiliT TOUCH Syringe, REF: IN8VCF/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8140/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | BlueFIRE Inflation Device, REF: IN10140 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixSKY Inflation Device, REF: SKY1802 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, 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 |
| May 13, 2024 | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... | Class II | Roche Diabetes Care, Inc. |
| 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 | 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 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 29, 2024 | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 4, 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... | Unreleased software was installed on customer systems resulting in the visual feedback on the scr... | Class II | Stryker Leibinger GmbH & Co. KG |
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Class II | Alcon Research, LLC |
| Mar 12, 2024 | SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | SmartPath to dStream for 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Jan 8, 2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... | Class II | Microbiologics Inc |
| Jan 3, 2024 | SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
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.