Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS… — Class II medical device recall Z-0311-2026
Ongoing recall by Aesculap Inc, reported 2025-11-05, distributed nationwide. It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
| Recall number | Z-0311-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Inc, Center Valley, PA, United States |
| Recall initiated | 2025-09-24 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 26 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046963425272 |
| Lot numbers | 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417 |
| Model numbers | EK086P |
Product
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Reason for recall
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0311-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.