Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0309-2026 — 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

U.S. FDA — Device Enforcement · United States · 2025-09-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0309-2026
Date of alert
2025-09-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04046963417710
Reported risk: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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