FDA Device recall Z-1243-2024
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures by Aesculap, citing the sterile blister packaging may be damaged, and sterility may be compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1243-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-09 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aesculap |
| Distribution | US |
Product
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Reason
The sterile blister packaging may be damaged, and sterility may be compromised.
Identifiers
| code_info | Product Code: EK224SU; UDI/DI: 04046963620424; Batch Numbers (Expiration Date): 52658689 (12/08/2023), 52625350 (07/31/2025), 52567841 (11/30/2024); |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2024%22
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