Z-1877-2018Class II

Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

Name: Z-1877-2018 Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Creator: Micro-Tech (Nanjing) Co., Ltd.
Published: 2018-03-12
License: https://open.fda.gov/license/

Micro-Tech (Nanjing) Co., Ltd. / initiated 2018-03-12 / Terminated / root cause: design

FDA source

Micro-Tech (Nanjing) Co., Ltd. began a recall of Trident Endoscopic Ultrasonic Biopsy Needle (FNB) on 2018-03-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1877-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-05-15
Terminated: 2018-08-30
Recalling firm: Micro-Tech (Nanjing) Co., Ltd.
Product: Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Product code: ODG Endoscopic Ultrasound System, Gastroenterology-Urology
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.
Root cause tag: design
FDA 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 in commerce: 40 total
Distribution: US distribution to one distributor in MI.
Product codes and lots: Identifier EUS-22-1-N UPN ES34591 M171226171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1877-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1877-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1878-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code ODG

K172309Class IIEndoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. / cleared 2017-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)