[pending] Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P S
Pending LLM rewrite. Source: FDA_DEVICE Z-0310-2026.
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 CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP 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 (12)
- Model No EK085P
- UDI-DI: 04046963620042
- Lots 52987668
- 52993442
- 53001930
- 53008562
- 53013543
- 52948710
- 52954233
- 52957528
- 52966111
- 52979586
Distribution
Distributed nationwide across the United States.
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