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

Aesculap Inc: Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUC

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 EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

UPC codes

04046963417710

Source

Official record: FDA (Device enforcement)

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

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