95,025 total recalls in our database
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
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Roche Diagnostics Operations
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
Biomet 3i
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
No results/incorrect results due to failure of the hybridization heater.
Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.
There have been reports of the suction catheter coming apart from the device assembly during use.
Roche Diagnostics Operations
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
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
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Zimmer Biomet
The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Siemens Healthcare Diagnostics
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
CHANGE HEALTHCARE CANADA COMPANY
Software defect which may potentially result in one or more images missing in a study
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
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Westinghouse Lighting, of Philadelphia, Pa.
The fan blades can crack and break, posing an impact injury hazard.
Spokane Produce
Salmonella Newport. Product contains onion supplied from Thomson International, Inc.