Micro-Tech recalls Trident Endoscopic Ultrasonic Aspiration Needles (FNA) due to potential needle breakage in the body during use, which could cause injury. Affected units include specific model identifiers.
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.
Micro-Tech is recalling Trident Endoscopic Ultrasonic Aspiration Needles (FNA) because the needle may break inside the body during use, potentially causing injury. This risk occurs when the needle is used with certain equipment and conditions.
The needle may break inside the body when used with specific equipment and conditions, such as the firmness of the tissue, the endoscope position, and the force needed to penetrate the mass. This breakage could cause injury to the user.
Medical professionals using the Trident Endoscopic Ultrasonic Aspiration Needle (FNA) for procedures are most at risk. Patients undergoing these procedures with the affected needles could also be impacted.
Check for the model identifier EUS-22-0-N, UPN ES34601, or M171226172 on the needle packaging or label. The product was sold by Micro-Tech (Nanjing) Co., Ltd.
Look for the model identifiers EUS-22-0-N, UPN ES34601, or M171226172 on the needle packaging or label.
The needle may break inside the body during use, which could cause injury due to the combination of tissue firmness, endoscope position, and force required to penetrate the mass.
Check for the model identifiers EUS-22-0-N, UPN ES34601, or M171226172 on the needle packaging or label.
The recall record does not specify a remedy, so contact Micro-Tech (Nanjing) Co., Ltd. for further instructions.
We’ve drafted a message you can send Micro-Tech to request your refund or repair — edit it as you like.
Subject: Recall Z-1878-2018 — Micro-Tech Micro-Tech Hello, I own a Micro-Tech that is covered by recall Z-1878-2018 from Micro-Tech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
