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RecallWatchMedical Device Safety
Class IIOngoingZ-0310-2026

Aesculap Inc recalls Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Numb…

Aesculap IncCenter Valley, PA, United StatesReported Nov 5, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Model
EK085P
UDI
04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586

What the firm is doing

On September 24, 2025 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken. 1. Review the recall notice and ensure all users in the organization are notified. Forward this notification to customers. Remove affected units from inventory, quarantine the product but do not destroy it. Complete and return the included response form. Return affected units to the firm. Credit of the product will be issued. An alternative disposable universal seal is available and can be ordered.

DistributionShow details

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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