🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
All Recalls
95,114 total recalls in our database
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Infusion Pump Repair
🏥 Medical Devices Class I - Dangerous
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
STEP-HAR MEDICAL
🏥 Medical Devices Class I - Dangerous
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
St. Jude Medical, Cardian Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Medical Action Industries, Inc. 306
🏥 Medical Devices Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical Action Industries, Inc. 306
🏥 Medical Devices Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
NM/CT 860 Nuclear Medicine / CT Scanners
GE Healthcare
🏥 Medical Devices Class I - Dangerous
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Regard Dressing Change Tray
ROi CPS
🏥 Medical Devices Class I - Dangerous
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Emergency Use Application (EUA) application withdrawn as false negative results reported
🏥 Medical Devices Class I - Dangerous
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
🏥 Medical Devices Class I - Dangerous
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.