Brand Name: Aesculap Product Name: Sealing Unit FOR 10/12MM Trocars recall: It was determined there is the potential of silicone fragments detaching
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0311-2026
- Published
- November 5, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Aesculap Inc
- Product type
- Medical devices
- Units affected
- 26 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
- UPC codes
- 04046963425272
Products covered by this recall
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
Check your product
The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 04046963425272
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 52968398
- 52975386
- 52988022
- 52993532
- 53008999
- 53009000
- 53009001
Model or item number
On the rating label, the box or the instruction sheet.
- EK086P Software Version
- EK086P
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Aesculap Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Aesculap Inc — 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Aesculap Inc medical devices recalled?
It was determined there is the potential of silicone fragments detaching from the yellow sealing component. It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 04046963425272; lot code 52968398, 52975386, 52988022; model number EK086P Software Version, EK086P. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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