Recall Z-0311-2026 ยท GCJ Laparoscope, General & Plastic Surgery
Aesculap Inc
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
| Date | Oct 24, 2025 (initiated Sep 24, 2025) |
| Status | Open, Classified |
| Reason | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 26 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.