Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 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 922 FDA device recalls in WI.

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Date	Product	Reason	Class	Firm
May 29, 2015	GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiograph...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance...	Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our EL...	Class II	Mortara Instrument, Inc
May 29, 2015	GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in genera...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 29, 2015	GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generatin...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare
May 4, 2015	GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).	The heart rate could be calculated from pacer pulses without indication that pacemaker detection ...	Class II	GE Healthcare
Apr 24, 2015	D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with...	A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe...	Class II	GE Healthcare
Apr 22, 2015	CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designe...	GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of th...	Class II	GE Healthcare
Apr 9, 2015	Merge RadSuite software. Radiological image processing system.	When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ...	Class II	Merge Healthcare, Inc.
Mar 30, 2015	Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-000...	The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is ...	Class II	Merge Healthcare, Inc.
Mar 12, 2015	GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate ...	GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of...	Class II	GE Healthcare
Mar 9, 2015	GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF...	GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ...	Class II	GE Healthcare
Mar 9, 2015	Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, ...	GE Healthcare has recently become aware of an improper installation of a ceiling suspended penden...	Class II	GE Healthcare
Mar 5, 2015	GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine system...	GE Healthcare has recently become aware of a potential safety issue due to a collimator falling o...	Class II	GE Healthcare
Mar 5, 2015	Merge LIS software.	There is a potential for duplicate container numbers to be created for patients.	Class II	Merge Healthcare, Inc.
Feb 27, 2015	GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers...	Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circ...	Class II	GE Healthcare
Feb 20, 2015	Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured...	The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that ...	Class II	TITAN SPINE, LLC
Feb 16, 2015	GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbe...	Potential safety issue due to improper assembly associated with the power cords of T2100 and T200...	Class II	GE Healthcare
Feb 2, 2015	Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw...	A component failure could cause a situation where the applied torque was significantly higher tha...	Class II	Bradshaw Medical Inc.
Jan 30, 2015	GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended ...	Potential breakage of the steel cable which supports the bucky device in certain wall stands of P...	Class II	GE Healthcare
Jan 27, 2015	GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model ...	Potential failure of the caster mounting hardware, which may result in the ventilator falling/tip...	Class II	GE Healthcare
Jan 21, 2015	Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Ma...	A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, result...	Class II	Merge Healthcare, Inc.
Jan 14, 2015	Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery s...	Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certa...	Class II	INO Therapeutics (dba Ikaria)
Jan 7, 2015	This correction applies to all GE Healthcare MRI systems with superconducting...	At certain sites, the MRU may not be connected to the magnet. In emergency situations, a discon...	Class I	GE Healthcare
Dec 19, 2014	GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.	Potential safety issue due to a required torque check on three bolted joints of the Revolution CT...	Class II	GE Healthcare
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 19, 2014	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx	An issue was identified with the mAs accuracy check performed on the system that could result in ...	Class II	GE Healthcare
Dec 15, 2014	PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits...	Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead ...	Class II	Genetic Testing Institute,inc
Dec 10, 2014	GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : ...	Potential unintentional system motion or rotation due to a positioning user interface issue with ...	Class II	GE Healthcare
Dec 8, 2014	GE Healthcare, Proteus XR/a with wall stand model number 600-0301.	GE Healthcare has recently become aware of a potential safety issue involving the breakage of the...	Class II	GE Healthcare
Nov 21, 2014	TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (H...	Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System ...	Class II	TomoTherapy Incorporated
Nov 12, 2014	The Revolution CT is a multi-slice (256 detector row) CT scanner consisting o...	A required quality control test was not performed during installation associated with the softwar...	Class II	GE Healthcare
Oct 24, 2014	GE Discovery MR950 MRI system	The alignment lasers are missing the labels required by radiation safety regulations.	Class II	GE Healthcare
Oct 17, 2014	INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0...	An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid...	Class II	INO Therapeutics (dba Ikaria)
Oct 14, 2014	GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infini...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst...	GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preve...	Class II	GE Healthcare, LLC
Oct 10, 2014	Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 B...	Silver Star Brands is recalling the Transport Chair and Rollator in One because they have receive...	Class II	Silver Star Brands

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.