Trident Endoscopic Ultrasonic Biopsy Needle — Class II medical device recall Z-1877-2018
Terminated recall by Micro-Tech (Nanjing) Co., Ltd., reported 2018-05-23. The combination of the firmness of the mass, the potential endoscope and elevator position combined with the f
| Recall number | Z-1877-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-Tech (Nanjing) Co., Ltd., Nanjing, China |
| Recall initiated | 2018-03-12 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2018-08-30 |
| Quantity | 40 total |
| Reason classes | device malfunction |
Product
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.