FDA Medical Device Recalls (openFDA)
Micro-Tech (Nanjing) Co., Ltd.: Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
- Recall number
- Z-1878-2018
- Recalling firm
- Micro-Tech (Nanjing) Co., Ltd.
- Product
- Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
- Status
- Terminated
- Initiated
- 2018-03-12
- Posted
- not on file
- Terminated
- 2018-08-30
- 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.
- Root cause
- Device Design
- Action
- The firm emailed the distributor on March 12, 2018. (initial consignee). The consignee has been requested to return all products to the Manufacturer (Micro-Tech Nanjing).
- Quantity
- 40 total
- Distribution
- US distribution to one distributor in MI.
- Lot, serial or model codes
- Identifier EUS-22-0-N UPN ES34601 M171226172
- 510(k) numbers
- ["K172309"]
- PMA numbers
- not on file
- Product code
- ODG
- Firm FEI
- 3004837686
- Firm city
- Nanjing National Nanjing
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28