# FDA recall Z-0309-2026

> **Aesculap Inc** · Class II · device recall initiated 2025-09-24.

## 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

- **Recall number:** Z-0309-2026
- **Recalling firm:** Aesculap Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0309-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0309-2026. Source: US FDA. Licensed CC0.

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