Z-1243-2024Class II

DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures

Name: Z-1243-2024 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures
Creator: Aesculap Inc
Published: 2024-01-09
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2024-01-09 / Open, Classified / root cause: packaging

FDA source

Aesculap Inc began a recall of DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures on 2024-01-09. FDA classified it as Class II and gives the reason as "The sterile blister packaging may be damaged, and sterility may be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1243-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2024-03-01
Recalling firm: Aesculap Inc
Product: DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: The sterile blister packaging may be damaged, and sterility may be compromised.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated January 5, 2024 were sent to customers. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.
Quantity in commerce: 12 pieces
Distribution: Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Product codes and lots: Product Code: EK224SU; UDI/DI: 04046963620424; Batch Numbers (Expiration Date): 52658689 (12/08/2023), 52625350 (07/31/2025), 52567841 (11/30/2024);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1243-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1243-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1244-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1245-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1246-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1247-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

Product code GCJ

K101937Class IIHybrid Trocar SystemAesculap, Inc. / cleared 2010-08-11

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)