Class II — Micro-Tech (Nanjing) Co., Ltd.
| Recalling firm | Micro-Tech (Nanjing) Co., Ltd. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Trident Endoscopic Ultrasonic Aspiration Needle (FNA) |
| Quantity | 40 total |
| Distribution | US distribution to one distributor in MI. |
| Initiated | 2018-03-12 |
| Classified | 2018-05-15 |
| Terminated | 2018-08-30 |
| Recall number | Z-1878-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Micro-Tech (Nanjing) Co., Ltd. (Z-1878-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79911/
Alerts for Micro-Tech (Nanjing) Co., Ltd.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.