FDAOctober 28, 2016device
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
What to do
FDA enforcement status: Terminated
Brands named
integra york paintegraintegra york
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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