Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Versio
FDA device recall Z-0309-2026 · posted 2025-10-24 · Open, Classified
Recall details
- Recalling firm
- Aesculap Inc
- Reason for recall
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 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.
- Date initiated
- 2025-09-24
- Date posted
- 2025-10-24
- Location
- Center Valley, PA
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