Recall Z-0311-2026
Aesculap Inc · initiated September 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
Reason for recall
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
FDA-determined 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.
Details
- Recall number
- Z-0311-2026
- Initiated
- September 24, 2025
- Posted by FDA
- October 24, 2025
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- 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.
- Recalling firm
- Aesculap Inc, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0309-2026 Class II | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0310-2026 Class II | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number:…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0312-2026 Class II | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |