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
- Company
- Aesculap Inc
- Recall Initiated
- September 24, 2025
- Posted
- October 24, 2025
- Recall Number
- Z-0311-2026
- Quantity
- 26 units
- Firm Location
- Center Valley, PA
Reason for Recall
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
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.
Lot / Code Info
Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
Root Cause
Under Investigation by firm
Action Taken
On September 24, 2025 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken. 1. Review the recall notice and ensure all users in the organization are notified. Forward this notification to customers. Remove affected units from inventory, quarantine the product but do not destroy it. Complete and return the included response form. Return affected units to the firm. Credit of the product will be issued. An alternative disposable universal seal is available and can be ordered.