Z-0309-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- September 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
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.
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.
Code Information
Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167