RegWardenFDA facility compliance records
Facility

Micro-Tech (Nanjing) Co., Ltd.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 2 recalls20172201820192020202120222023202420252026
  • Recalls (2)

Devices registered here (1)

  • Endoscopic Injection Needle, Gastroenterology-Urology
    Product code FBK (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

  • Class IITerminated2018-09-20
    Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
  • Class IITerminated2018-03-12
    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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Micro-Tech (Nanjing) Co., Ltd. (FEI 3004837686) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004837686-micro-tech-nanjing-co-ltd/

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