🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
All Recalls
95,018 total recalls in our database
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Signature Orthopedics Pty Limited
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
There is a potential for abnormal inflation of the mattress.
🏥 Medical Devices 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
🏥 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
Products distributed as sterile may not have been adequately sterilized
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
MARVAO MEDICAL DEVICES
🏥 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.
🏥 Medical Devices Class I - Dangerous
Sterility issues; single use devices labeled 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
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
🏥 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
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
🏥 Medical Devices Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏥 Medical Devices Class I - Dangerous
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
CamelBak Podium and Peak Fitness water bottles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
A small silicone valve in caps sold with the Podium and Peak Fitness water bottle can come loose and detach, posing a choking hazard.