Class I - Dangerous
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class I - Dangerous
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Class I - Dangerous
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Neoprobe GDS Control Unit, Model Number NPCU3
Devicor Medical Products
Class I - Dangerous
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Class I - Dangerous
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Class I - Dangerous
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Roche Diagnostics Operations
Class I - Dangerous
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Class I - Dangerous
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class I - Dangerous
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Change Healthcare Radiology Solutions 14.0
CHANGE HEALTHCARE CANADA COMPANY
Class I - Dangerous
Software defect which may potentially result in one or more images missing in a study
Class I - Dangerous
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Class I - Dangerous
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.