Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
All Recalls
95,089 total recalls in our database
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
🏥 Medical Devices Class I - Dangerous
Edits to Particle field definition parameters may not be saved when the field definition window is saved.
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069.
🏥 Medical Devices Class I - Dangerous
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
🏥 Medical Devices Class I - Dangerous
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
ErgoSafe Products, LLC (DBA) Prism Medical
🏥 Medical Devices Class I - Dangerous
The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.
GE Healthcare, Avance, Avance CS2, Amingo.
GE Healthcare
🏥 Medical Devices Class I - Dangerous
GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.
The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
🏥 Medical Devices Class I - Dangerous
GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Software malfunction that results in incorrect generation or display of error codes.
🏥 Medical Devices Class I - Dangerous
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
🏥 Medical Devices Class I - Dangerous
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing