The Recall Desk
HighFDA (Devices)·Z-1878-2018·Announced 2018-05-23

Micro-Tech Trident Endoscopic Ultrasonic Aspiration Needle Recalled for Breakage Risk

Micro-Tech (Nanjing) Co., Ltd. is recalling 40 Trident Endoscopic Ultrasonic Aspiration Needles because they may break in the human body, potentially causing injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of injury due to breakage in the human body, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Micro-Tech (Nanjing) Co., Ltd. is recalling 40 units of the Trident Endoscopic Ultrasonic Aspiration Needle (FNA). The product was distributed in the United States to one distributor in Michigan.

The recall was initiated because the needle may break in the human body. The firmness of the mass being sampled, the position of the endoscope and elevator, and the force required to penetrate the mass may contribute to this breakage, which could cause injury.

Consumers and healthcare providers should stop using the affected needles and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Identifier EUS-22-0-N UPN ES34601 M171226172

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Micro-Tech (Nanjing) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Micro-Tech (Nanjing) Co., Ltd.

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