Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Meta C.G.M. Spa
Class I - Dangerous
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Philips North America
Class I - Dangerous
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized