August 12, 2020Medical DevicesFDA
Boss Instruments, Ltd. recalls BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic clean
Hazard: The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.