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