Ethicon Endo-Surgery ECHELON 80 mm Blue Linear Cutter Recalled for Unsterilized Shipment (3 Units, 3
The devices were shipped unsterilized.
1,320 recalls tagged with “fda regulated”.
The devices were shipped unsterilized.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott recalled 3,403 TactiFlex Sensor Enabled Ablation Catheters sold worldwide. The devices may detach a tip during removal from packaging. Hospitals and providers should stop using the devices and follow the manufacturer’s recall instructions.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott recalls 399 TactiFlex Sensor Enabled Ablation Catheters after reports of tip detachment during packaging removal. The recall covers devices worldwide. Stop using the device immediately and follow manufacturer instructions.
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Potential that the measured value may be smaller than the actual area.
Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.