[pending] Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-0309-2026.
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 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
- 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 (13)
- Model No EK083P
- UDI-DI: 04046963417710
- Lots 52978946
- 52991996
- 53002275
- 53004669
- 53006807
- 52941286
- 52956527
- 52956740
- 52956952
- 52957393
- 52967167
Distribution
Distributed nationwide across the United States.
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