Browse Device Recalls

3,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,550 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 3,550 FDA device recalls in MA.

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DateProductReasonClassFirm
Sep 10, 2026 NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX ... Class II Boston Scientific Corporation
Sep 4, 2026 LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wro... Class III Magellan Diagnostics, Inc.
Sep 3, 2026 HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Class I Instrumentation Laboratory
Sep 3, 2026 HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (... Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Class I Instrumentation Laboratory
Aug 28, 2026 TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; Devices failed in process testing related to the amount of pull force it can sustain prior to the... Class II LeMaitre Vascular, Inc.
Aug 28, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R1... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S),... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software V... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; So... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 a... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 78... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. ... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 28, 2026 MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; So... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... Class II Philips North America
Aug 28, 2026 Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3... When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... Class II Philips North America
Aug 21, 2026 Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.);... Software issues may affect the safety and performance of Spectral CT system(s). The issues may re... Class II PHILIPS MEDICAL SYSTEMS
Aug 21, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 5300 Model Number (REF): 1. 782110, 2. 782152; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 18, 2026 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots ma... Class II Philips North America Llc
Aug 12, 2026 GM Helix Implant, REF: 109.984; There is a discrepancy between the product identification on the packaging and the dimensions of ... Class II Straumann USA LLC
Aug 12, 2026 Impella Optical Controller, Automated Impella Controller, Impella Connect Pac... The potential for purge cassette recognition issues due to the failure of the purge flag componen... Class I Abiomed, Inc.
Aug 12, 2026 Impella Optical Controller with the below product descriptions and correspond... The potential for purge cassette recognition issues due to the failure of the purge flag componen... Class I Abiomed, Inc.
Aug 12, 2026 Automated Impella Controller (AIC) with the below product descriptions and co... The potential for purge cassette recognition issues due to the failure of the purge flag componen... Class I Abiomed, Inc.
Aug 10, 2026 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-51... Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 7, 2026 Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Jul 31, 2026 Philips Patient Information Center iX REF:866389 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 31, 2026 Philips PIC iX Essentials REF:867093 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 29, 2026 CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transduc... Communication to recommend reviewing the IFU and ensuring that all treatment preparation and hand... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical 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.