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

Medical DevicesSource: FDA (device) · Date: 2025-11-05

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Aesculap Inc
Product
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/A
Reason / hazard
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-09-24
Code info
Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
Product quantity
26 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
97649
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