Recall Z-0309-2026— Aesculap Inc

Name: FDA recall Z-0309-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-24

Class II · Ongoing

Class II FDA medical device recall by Aesculap Inc, initiated 2025-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component..

Recalling firm: Aesculap Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-09-24
Firm location: Center Valley, PA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.