Browse Device Recalls

685 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 685 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 685 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 3, 2015	Philips Healthcare Xper vascular system Model : 722124 Product Usage: ...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Feb 3, 2015	Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Feb 3, 2015	Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Feb 3, 2015	Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Feb 3, 2015	Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Feb 3, 2015	Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag...	Monitor Ceiling Suspension system may fall	Class II	Philips Medical Systems, Inc.
Jan 23, 2015	Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode...	Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installatio...	Class II	Philips Medical Systems, Inc.
Dec 23, 2014	HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ...	MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b...	Class II	Philips Medical Systems, Inc.
Dec 19, 2014	Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i...	Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification	Class II	Philips Medical Systems, Inc.
Dec 8, 2014	Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit ...	Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.	Class II	Philips Medical Systems (Cleveland) Inc
Nov 20, 2014	Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg...	VCG battery ignited in a VCG unit when recharging.	Class II	Philips Medical Systems, Inc.
Nov 19, 2014	Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliV...	Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneou...	Class II	Philips Medical Systems, Inc.
Nov 19, 2014	Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A	1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor...	Class II	Philips Medical Systems, Inc.
Nov 19, 2014	Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ...	MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid...	Class II	Philips Medical Systems, Inc.
Nov 19, 2014	HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,...	Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte...	Class II	Philips Medical Systems, Inc.
Nov 12, 2014	BrightView model number: 882478 BrightView X model number: 882480 BrightVie...	Unintended detector and gantry movement due to software issues.	Class II	Philips Medical Systems (Cleveland) Inc
Nov 9, 2014	IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/...	Software defect. In certain circumstances, the application may display incorrect measurements of...	Class II	Philips Medical Systems (Cleveland) Inc
Nov 4, 2014	BrightView product code: 882478 BrightView X product code: 882480 BrightVie...	Software issues	Class II	Philips Medical Systems (Cleveland) Inc
Oct 10, 2014	Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an...	Mold on gel filled Gel-E and Squishon products	Class I	Philips Medical Systems, Inc.
Oct 9, 2014	MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can ...	"The orientation of images is displayed incorrectly. When operator chooses gantry on the ri...	Class II	Philips Medical Systems (Cleveland) Inc
Oct 3, 2014	Philips Avalon Monitors with software revision J.30.58: Model Product F...	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB...	Class II	Philips Medical Systems, Inc.
Oct 3, 2014	Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo...	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB...	Class II	Philips Medical Systems, Inc.
Sep 24, 2014	Foot Switches used with the following systems: Philips Allura Xper Systems; 7...	Loss of key image functionality due to a bent pedal of the Footswitch.	Class II	Philips Medical Systems, Inc.
Sep 24, 2014	Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ...	Loss of key image functionality due to a bent pedal of the Footswitch.	Class II	Philips Medical Systems, Inc.
Sep 11, 2014	The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed...	Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order tha...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 21, 2014	Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions...	When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,...	Class II	Philips Medical Systems, Inc.
Aug 19, 2014	Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Mod...	The hook does not securely hold the footplate in vertical position. Therefore the footplate can f...	Class II	Philips Medical Systems, Inc.
Aug 19, 2014	Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Mo...	The hook does not securely hold the footplate in vertical position. Therefore the footplate can f...	Class II	Philips Medical Systems, Inc.
Aug 8, 2014	Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system	Philips had discovered through a field service testing where a device failed to comply with a Fe...	Class II	Philips Medical Systems, Inc.
Aug 7, 2014	Philips IntelliSpace ECG Management System, with software option C61 needed ...	Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q...	Class II	Philips Medical Systems, Inc.
Jul 31, 2014	Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th...	It was discovered that a software defect may result in the scanner not terminating the CT scan a...	Class II	Philips Medical Systems, Inc.
Jul 27, 2014	IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli...	The following software issues have been identified in the affected products. Problem 1: When reo...	Class II	Philips Medical Systems (Cleveland) Inc
Jul 8, 2014	Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ...	Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli...	Class II	Philips Medical Systems, Inc.
Jul 8, 2014	Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste...	Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handli...	Class II	Philips Medical Systems, Inc.
Jun 23, 2014	BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat...	Flat Panel Display (FPD) failed to remain securely locked in the deployed position.	Class II	Philips Medical Systems (Cleveland) Inc
Jun 18, 2014	GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: ...	When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to ...	Class II	Philips Medical Systems (Cleveland) Inc
Jun 13, 2014	Ingenia 1.5T R5, magnetic resonance imaging system.	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ...	Class II	Philips Medical Systems, Inc.
Jun 13, 2014	Ingenia 1.5T, magnetic resonance imaging system.	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ...	Class II	Philips Medical Systems, Inc.
Jun 13, 2014	Ingenia 3.0T R5, magnetic resonance imaging system.	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ...	Class II	Philips Medical Systems, Inc.
Jun 13, 2014	Ingenia 3.0T, magnetic resonance imaging system.	For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ...	Class II	Philips Medical Systems, Inc.
Jun 6, 2014	Philips Medical System Allura Xper X-Ray Angiographic	In certain circumstances, a software error can lead to a situation where the five minute fluorosc...	Class II	Philips Medical Systems, Inc.
May 22, 2014	IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I...	IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume...	Class II	Philips Medical Systems, Inc.
May 15, 2014	Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T pro...	Ingenia customers have experienced clamping of the foot under the central column of the Height Ad...	Class II	Philips Medical Systems, Inc.
May 15, 2014	Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T prod...	Ingenia customers have experienced clamping of the foot under the central column of the Height Ad...	Class II	Philips Medical Systems, Inc.
May 5, 2014	All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R...	In spine clinical workflows, cross reference lines may be used to determine the position of slice...	Class II	Philips Medical Systems, Inc.
Apr 8, 2014	Intended for both adult and pediatric patients for taking diagnostic radiogra...	In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an un...	Class II	Philips Medical Systems, Inc.
Apr 4, 2014	Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor...	The risk of battery failure increases with age, when a battery remains in use longer than 3 years...	Class II	Philips Medical Systems, Inc.
Apr 2, 2014	Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli...	Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ...	Class II	Philips Medical Systems, Inc.
Apr 2, 2014	Philips HeartStart XL+ Defibrillator/Monitor with system software version B....	Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m...	Class II	Philips Medical Systems, Inc.
Apr 1, 2014	Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT seri...	A customer reported that the table top had become free floating. A Field Service Engineer (FSE) ...	Class II	Philips Medical Systems (Cleveland) Inc

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.