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Kirwan

KIRWAN SURGICAL PRODUCTS LLC · Model 12-1436AUS · UDI-DI 00841019122136

GEI Prescription

510(k) clearances

118,289

Adverse events (469 deaths)

644

Recalls

855

Facilities

Description

Reusable Bipolar Forceps with Tip Angled Down 45 Degrees at 3mm, Insulate to the Angle, and 6" Working Length (Special)

Recalls

Date	Firm	Reason
2026-08-18	Olympus Corporation of the Americas	Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-02	Maquet Cardiovascular, LLC	Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-02-25	Olympus Corporation of the Americas	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For
2026-02-25	Olympus Corporation of the Americas	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For

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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.