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.

Clear

Date	Product	Reason	Class	Firm
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
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

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.