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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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total 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
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
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.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Ra Medical Systems
Class I - Dangerous
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
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
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Biomet 3i
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
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.
Class I - Dangerous
There have been reports of the suction catheter coming apart from the device assembly during use.
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
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.