Aesculap Inc: Device Recall

Recall #Z-0309-2026 · 09/24/2025

Class II: Risk

Recall Details

Recall Number: Z-0309-2026
Classification: Class II
Product Type: Device
Recalling Firm: Aesculap Inc
Status: Ongoing
Date Initiated: 09/24/2025
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 units

Reason for Recall

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Product Description

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A

Distribution Pattern

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.

Other Recalls by Aesculap Inc

Class II: Risk 09/24/2025

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 09/24/2025

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 09/24/2025

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Class II: Risk 01/31/2025

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Class II: Risk 01/31/2025

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

View all recalls by Aesculap Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.