FDAHealthSeptember 24, 2025
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 Compone
⚠️ It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 24, 2025
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.
What's affected?
- 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
- Brand
- Aesculap Inc
- Lot code
- 52968398
Additional details
Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26 units.
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