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.

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DateProductReasonClassFirm
Nov 30, 2023 BrightView X, Gamma Camera, Product Code 882478 While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created be... Class II Philips North America
Nov 30, 2023 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... The bolus calculator is not recording the decimal point if it is the first value entered when cha... Class I Insulet Corporation
Nov 29, 2023 Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 The device may experience mechanical interference on the Fluid Valve pins, which will trigger a P... Class I Fresenius Kabi USA, LLC
Nov 28, 2023 (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 Push notifications may fail to send to the user under certain conditions. This could potentially ... Class II Philips North America
Nov 28, 2023 (1) Patient Information Center iX, Model No. 866389 (2) Patient Information ... Push notifications may fail to send to the user under certain conditions. This could potentially ... Class II Philips North America
Nov 23, 2023 The device is a mobile x-ray system designed to work with Fujifilm's GOS and ... When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.... Class II FUJIFILM Healthcare Americas Corporation
Nov 17, 2023 Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7... Firm was informed of an event in which the structural integrity of the MR system components faile... Class I Philips North America Llc
Nov 16, 2023 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentia... Class II Covidien LP
Nov 7, 2023 Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 24, 2023 Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... Class III Fresenius Medical Care Holdings, Inc.
Oct 23, 2023 Intera 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Intera 1.5T Power/Pulsar Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Conversion Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Initial System Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Achieva 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 Ingenia 1.5T CX Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 23, 2023 SmartPath to dStream for 1.5T Potential component failure in the Gradient Coil could product smoke and/or fire. Class II Philips North America Llc
Oct 19, 2023 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... Class II Siemens Healthcare Diagnostics Inc
Oct 17, 2023 Lugol s Iodine Solution 500ML, Part Number 624-71 Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap ... Class II EMD Millipore Corporation
Oct 13, 2023 with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 0060... Produced with unintended open slits on the side of the mouthpiece body, may result in insufficien... Class II Breas Medical, Inc.
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-000-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-040-US with software ... Pump not detected as connected to controller due to software issue. Class II Abiomed, Inc.
Oct 10, 2023 Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025 One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly cont... Class II Beaver Visitec International, Inc.
Oct 10, 2023 Stay Safe Cap Updating the labeling to include additional warnings and contraindications for potential side eff... Class II Fresenius Medical Care Holdings, Inc.
Oct 9, 2023 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... Class II Philips North America
Oct 9, 2023 Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... Class II Philips North America Llc
Oct 9, 2023 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... Class II Philips North America
Oct 4, 2023 Integris-Allura IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Azurion IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Zenition 50 & 70 Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Veradius Unity Mobile Surgery C-arm Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Oct 4, 2023 Allura Xper IGTS Fixed Systems Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... Class II Philips North America
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... Class II Instrumentation Laboratory
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... Class II Instrumentation Laboratory

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.