Reported Nov 5, 2025 · Ongoing

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software…

Aesculap Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aesculap Inc · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217

Is this the product you have?

  • Brand NameAesculap
  • Product NameSEALING UNIT F/10/12MM TROCARS W
  • REDUCER Model/Catalog NumberEK083P
  • Software VersionN/A
  • Product DescriptionSEALING UNIT F/10/12MM TROCARS W
  • REDUCER ComponentN/A
Lot codes and dates
  • Model No EK083P
  • UDI-DI
    • 04046963417710
    • Lots 52978946
    • 52991996
    • 53002275
    • 53004669
    • 53006807
    • 52941286
    • 52956527
    • 52956740
    • 52956952
    • 52957393
    • 52967167
Amount recalled
26 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.