Browse Device Recalls

3,376 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,376 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 3,376 FDA device recalls in MA.

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Date	Product	Reason	Class	Firm
Jun 30, 2025	Upgrade to MR 7700 Model Number (REF): 782130;	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ...	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (...	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	Ingenia 1.5T S Model Number (REF): 781347;	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	SmartPath to dStream for 3.0T Model Number (REF): 782145;	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 30, 2025	Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (...	The potential for component failures in the Gradient Coil of the affected MR systems may act as a...	Class II	Philips North America
Jun 26, 2025	RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.	Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot W...	Class II	Siemens Healthcare Diagnostics Inc
Jun 24, 2025	LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F...	Potential for external cassette leaks	Class II	Fresenius Kabi USA, LLC
Jun 24, 2025	LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C...	Potential for external cassette leaks	Class II	Fresenius Kabi USA, LLC
Jun 24, 2025	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-...	Potential for external cassette leaks	Class II	Fresenius Kabi USA, LLC
Jun 24, 2025	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du...	Potential for external cassette leaks	Class II	Fresenius Kabi USA, LLC
Jun 23, 2025	Automated Impella Controller (AIC), used in left heart support blood pump, in...	A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ...	Class I	Abiomed, Inc.
Jun 11, 2025	ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t...	Devices had an unapproved slabbing software function enabled for use.	Class II	FUJIFILM Healthcare Americas Corporation
Jun 10, 2025	BostonSight PROSE Lens.	Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.	Class II	Boston Foundation For Sight
Jun 10, 2025	BostonSight SCLERAL Lens	Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.	Class II	Boston Foundation For Sight
May 29, 2025	Achieva XR Product Numbers: (1) 781153, (2) 781253;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Omni/Stellar; Product Number: 781104;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Master/Nova Product Number: 781106;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera Achieva 1.5T Pulsar; Product Number: 781171;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Achieva Nova Product Number: 781172;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Achieva IT Nova Product Number: 781175	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	SmartPath to dStream for 1.5T¿; Product Number: 782146;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Explorer/Nova Dual Product Number: 781108;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Intera 1.5T Achieva Nova-Dual Product Number: 781173;	identified an issue where a component failure in the specific Gradient Coil type of affected syst...	Class II	Philips North America
May 29, 2025	Spectral CT. Computed tomography X-ray system.	Devices with affected software may experience two unintended motion issues that may lead to conta...	Class II	Philips North America Llc
May 27, 2025	O-arm O2 Imaging System. Mobile X-Ray System.	A mechanical component that supports the O2 gantry to the support structure in affected devices m...	Class II	Medtronic Navigation, Inc.-Boxborough
May 23, 2025	Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P...	Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a com...	Class II	Insulet Corporation
May 13, 2025	Product Name: Upgrade to MR 7700; Model Number: 782130;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Allon 2001. Part Number: 200-00263	An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exce...	Class II	Belmont Instrument LLC
May 13, 2025	Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: SmartPath to dStream for 3.0T; Model Number: 782145	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia 1.5T S; Model Number: 781347;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) ...	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia 1.5T CX; Model Number: 781262;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Ingenia 3.0T CX; Model Number: 781271;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 13, 2025	Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;	Potential for alignment errors in the cross reference line functionality when reviewing images ge...	Class II	Philips North America Llc
May 12, 2025	IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low...	Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte...	Class I	Fresenius Kabi USA, LLC
May 7, 2025	Z-800F Infusion System. Intended to provide intravenous infusion of parentera...	Unreleased software versions were installed on distributed devices without verification or valida...	Class I	Zyno Medical 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.