DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU.… recallZ-1245-2024 · Aesculap Inc · initiated Jan 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The sterile blister packaging may be damaged, and sterility may be compromised.
FDA root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-1245-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2024
- Posted by the FDA
- Mar 1, 2024
- Recalling firm
- Aesculap Inc
- Quantity
- 6 pieces
- Product code
- GCJ
- FDA submissions
- K101937
- Distribution
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Product description
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Code information (models, lots, serial numbers)
Product Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AESCULAP EK234SUAesculap AG · Laparoscope, general & plastic surgery1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93856).
- Z-1243-2024 · Open, ClassifiedDISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
- Z-1244-2024 · Open, ClassifiedDISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
- Z-1246-2024 · Open, ClassifiedDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
- Z-1247-2024 · Open, ClassifiedDISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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