The Recall Desk
HighFDA (Devices)·Z-0311-2026·Announced 2025-11-05

Trocar sealing units recalled over silicone fragments detaching from sealing component

Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

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: Scored 3 under the risk-of-harm criterion: fragments detaching from a surgical access component could enter the patient, and no injuries are reported.

Plain-English summary

The AESCULAP Sealing Unit for 10/12mm Trocars, model EK086P, is being recalled.

It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

The recall covers 26 units carrying UDI-DI 04046963425272, across lots including 52968398, 52975386, 52988022, 52993532, 53008999 and 53009000. The product was distributed nationwide in the United States including Arkansas, Arizona, California, Connecticut, Maryland, Nebraska, New Mexico, New York, Oregon, Pennsylvania, Washington and Wisconsin, and internationally. The FDA has classified the action as Class II.

The enforcement record describes the fragment risk and reports no injuries. Facilities should quarantine affected lots and follow the firm's instructions.

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 — Surgical instrument
Hazard
Affected units
26

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.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Aesculap Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Aesculap Inc

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Same hazard · fragment detachment

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