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Recall Observatory FDA recall evidence

Device 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

Z-0309-2026

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-0309-2026

Official wording

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

Code information: Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

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.