Home › Scivita Medical Technology Co., Ltd. › Single-use Biopsy Forceps

Single-use Biopsy Forceps

Scivita Medical Technology Co., Ltd. · Model BFUW-1829E-YG · UDI-DI 06971381253191

FCL Prescription

510(k) clearances

2,705

Adverse events (17 deaths)

Recalls

190

Facilities

Description

The product is composed of a handle, a sliding handle, a flexible catheter and a head end, sterilized with ethylene oxide. This product is intended for biopsy of mucosal tissue and/or removal of foreign bodies under endoscope.

Recalls

Date	Firm	Reason
2026-06-30	Boston Scientific Corporation	Potential for breach in sterile barrier of device packaging.
2026-06-30	Boston Scientific Corporation	Potential for breach in sterile barrier of device packaging.
2026-06-30	Boston Scientific Corporation	Potential for breach in sterile barrier of device packaging.
2023-03-24	Richard Wolf GmbH	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open
2023-03-24	Richard Wolf GmbH	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open
2023-03-24	Richard Wolf GmbH	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open
2023-03-24	Richard Wolf GmbH	Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be open
2016-04-15	Cook Inc.	Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a devi
2010-05-06	Boston Scientific Corporation	Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
2010-05-06	Boston Scientific Corporation	Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.