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Disposable Hemostatic Clips

Ningbo Xinwell Medical Technology Co., Ltd. · Model XY-ZZJ-1B-2.5-1650-135-13 · UDI-DI 06974529068480

PKL Prescription

510(k) clearances

7,146

Adverse events (25 deaths)

Recalls

Facilities

Description

Disposable Hemostatic Clips

Recalls

Date	Firm	Reason
2026-03-03	Wilson-Cook Medical Inc.	Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2023-05-04	Olympus Corporation of the Americas	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten
2019-02-04	US Endoscopy Group Inc	Potential esophageal laceration during a patient procedure

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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.