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Recall Observatory FDA recall evidence

Device 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

Z-0311-2026

September 24, 2025

Class II

Product summary

Firm
Aesculap Inc
Event
Event 97649
Status
Ongoing
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-0311-2026

Official wording

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

Code information: Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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