🏥 Medical Devices Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
All Recalls
95,018 total recalls in our database
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Phasor Health
🏥 Medical Devices Class I - Dangerous
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Hamilton Medical AG
🏥 Medical Devices Class I - Dangerous
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
🏥 Medical Devices Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
🏥 Medical Devices Class I - Dangerous
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Fresenius Kabi USA
🏥 Medical Devices Class I - Dangerous
Potential for external cassette leaks
🏥 Medical Devices Class I - Dangerous
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
🏥 Medical Devices Class I - Dangerous
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
HeartSine Technologies
🏥 Medical Devices Class I - Dangerous
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FUJIFILM Healthcare Americas
🏥 Medical Devices Class I - Dangerous
Devices had an unapproved slabbing software function enabled for use.
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Intera 3.0T Quasar Dual Model Number (REF): 781150;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Molding Equipment. WCM series. Model WCM-330GL-i
Apic Yamada America
🏥 Medical Devices Class I - Dangerous
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
LTS Therapy Systems
🏥 Medical Devices Class I - Dangerous
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.