FDA Enforcement
Class II
Ongoing
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
Recall: Z-0310-2026
·
Reported November 5, 2025
Enforcement
- Recall Number
- Z-0310-2026
- Event ID
- 97649
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aesculap Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2025
- Initiation Date
- September 24, 2025
- Classification Date
- October 24, 2025
- Address
- 3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States
Description
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
Reason
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code Info
Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586
Distribution
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.
Quantity
140 units