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Recall Observatory FDA recall evidence

Device product

Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A

Z-0310-2026

September 24, 2025

Class II

Product summary

Firm
Aesculap Inc
Event
Event 97649
Status
Ongoing
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-0310-2026

Official wording

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

Code information: Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586

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.