[pending] Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P
Pending LLM rewrite. Source: FDA_DEVICE Z-0311-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
The recalled product
- 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
- Manufacturer
- Aesculap Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model No EK086P
- UDI-DI: 04046963425272
- Lots 52968398
- 52975386
- 52988022
- 52993532
- 53008999
- 53009000
- 53009001
- 53009417
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27