Browse Device Recalls

3,378 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,378 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 3,378 FDA device recalls in MA.

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DateProductReasonClassFirm
Feb 21, 2024 Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC
Feb 20, 2024 EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition dir... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition d... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutri... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nut... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutr... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 15, 2024 DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... Class II Philips North America Llc
Feb 2, 2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... Pack and pouch label is missing the manufacturing and expiration date. Class II Beaver Visitec International, Inc.
Jan 29, 2024 NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessor... Product is recalled due to reports of blood leaking or spraying from the arterial line on the car... Class II NxStage MDS Corporation
Jan 26, 2024 Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a b... This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inv... Class II EMD Millipore Corporation
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

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.