Z-0309-2026Class II

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P...

Name: Z-0309-2026 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P...
Creator: Aesculap Inc
Published: 2025-09-24
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2025-09-24 / Open, Classified

FDA source

Aesculap Inc began a recall of Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING... on 2025-09-24. FDA classified it as Class II and gives the reason as "It was determined there is the potential of silicone fragments detaching from the yellow sealing component". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0309-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-24
Posted: 2025-10-24
Recalling firm: Aesculap Inc
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
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 26 units
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.
Product codes and lots: Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0309-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0309-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0310-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0311-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24
Z-0312-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-24

Product code GCJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)