FDA recall Z-0309-2026

Aesculap Inc · Class II · device

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 for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2025-09-24
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0309-2026