FDA (Devices) recall action 79911
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.
Micro-Tech (Nanjing) Co., Ltd. is recalling 40 Trident Endoscopic Ultrasonic Aspiration Needles because they may break in the human body, potentially causing injury.