Aesculap Inc recalls Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Versi…

Recall date

September 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0309-2026

FDA classification

Class II

Brand / firm

Aesculap Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.REDUCER Component: N/A