Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 23, 2024 | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Catheter Ext. 6 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 18 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Adapter 4 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 10, 2024 | Synapse PACS - Version 7.2.200 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000US | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| 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 |
| Jan 3, 2024 | Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse CV 6. with AR. A web-based application as the primary user interfa... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Achieva XR. Model (REF) Numbers 781153, 781253. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 28, 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm d... | Class II | NeuroLogica Corporation |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... | Class I | Abiomed, Inc. |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | New warnings are being added to the Instructions for Use for all affected products to reduce the ... | Class II | Abiomed, Inc. |
| Dec 21, 2023 | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 21, 2023 | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 20, 2023 | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... | Class II | Zyno Medical LLC |
| Dec 19, 2023 | EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac... | Class II | Boston Scientific Corporation |
| Dec 15, 2023 | BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 8824... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 15, 2023 | ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/... | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s ra... | Class II | Philips North America |
| Dec 15, 2023 | ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy... | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients rad... | Class II | Philips North America |
| Dec 15, 2023 | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12... | Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce... | Class I | Philips North America |
| Dec 13, 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 13, 2023 | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 7, 2023 | Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste... | If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope... | Class II | Philips North America |
| Dec 6, 2023 | Impella Connect, software portal for online device management that allows cli... | The following features have been disabled from the web-based portal because the FDA has not evalu... | Class II | Abiomed, Inc. |
| Nov 30, 2023 | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Multiple software issues that affect device functionality. | Class II | Philips North America Llc |
| Nov 30, 2023 | BrightView XCT, Gamma Camera, Product Code 882482 | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... | Class II | Philips North America |
| Nov 30, 2023 | BrightView, Gamma Camera System, Product Code 882480. | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... | 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.