Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver
Summary
The FDA issued a Class II for Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Mo by Aesculap Inc. Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component..
Details
Source
Device Recall
External ID
Z-0309-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
Quantity Affected: 26 units
Reason for Recall
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-24
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Inc have FDA actions?
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0309-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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