CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Trident Endoscopic Ultrasonic Biopsy Needle (FNB) recalled
Micro-Tech (Nanjing) Co is recalling Trident Endoscopic Ultrasonic Biopsy Needle (FNB), distributed in Michigan. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1877-2018
- FDA event ID
- 79911
- Recalling firm
- Micro-Tech (Nanjing) Co, Nanjing
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Mar 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 12 Mar 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +64 days |
| 23 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Where it was distributed
US distribution to one distributor in MI.
Questions about this recall
Is Trident Endoscopic Ultrasonic Biopsy Needle (FNB) recalled?
Yes. Micro-Tech (Nanjing) Co recalled Trident Endoscopic Ultrasonic Biopsy Needle (FNB) on 12 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1877-2018.
Why was it recalled?
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.
Which lots are affected?
Identifier EUS-22-1-N UPN ES34591 M171226171
Where was it sold?
US distribution to one distributor in MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Micro-Tech (Nanjing) Co
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|---|---|---|---|---|---|
| Device | CLASS II | Single-Use Biopsy Forceps, Jumbo Alligator recalled | Micro-Tech (Nanjing) Co | Sterility | Nationwide |
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