Aesculap Inc: Medical Device Recall in 2025 - (Recall #: Z-0309-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 24, 2025

Date Posted: November 5, 2025

Recall Number: Z-0309-2026

Event ID: 97649

Reason for Recall:

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

Status: Ongoing

Product Quantity: 26 units

Code Information:

Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

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.

Voluntary or Mandated:

Voluntary: Firm initiated