Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
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.
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Signature Orthopedics Pty Limited
Class I - Dangerous
Product mislabeled, with the incorrect product inside the package.
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Getinge (Suzhou) Co
Class I - Dangerous
There is a potential for abnormal inflation of the mattress.
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. 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
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
MARVAO MEDICAL DEVICES
Class I - Dangerous
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
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
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
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.
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. 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
ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized