ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Zavation
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Malware attack
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Zavation
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.
🏥 Medical Devices Class I - Dangerous
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
🏥 Medical Devices 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