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CLASS II · ModerateFDA

Aesculap Inc recalls Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER

📅 Sep 24, 2025 · 📍 Nationwide
Recalling company
Aesculap Inc
Product
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
Reason
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 24, 2025
Reported
Nov 5, 2025
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.
Status
Ongoing
Quantity
26 units
Lot / codes
Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
Company location
Center Valley, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-0309-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0309-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.