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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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)
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
- 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 →Related recalls
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