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FDA (Device enforcement)Recalled 2025-09-24class ii

Aesculap Inc: Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/

Hazard

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Details from the source

Reason for recall: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada. Quantity: 26 units Lot/code info: Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417

UPC codes

04046963425272

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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