🏥 Medical Devices • 15,809 recalls
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
IVOCLAR VIVADENT AG
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
IVOCLAR VIVADENT AG
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Baxter Healthcare
Product was distributed in the United States without proper regulatory approval.
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Ion Beam Applications S.A.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
XENEX Disinfection Services
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
LEICA BIOSYSTEMS NUSSLOCH GMBH
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.