FDA Medical Device Recalls (openFDA)
Aesculap Inc: DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
- Recall number
- Z-1245-2024
- Recalling firm
- Aesculap Inc
- Product
- DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
- Status
- Open, Classified
- Initiated
- 2024-01-09
- Posted
- 2024-03-01
- Terminated
- not on file
- Reason
- The sterile blister packaging may be damaged, and sterility may be compromised.
- 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
- 6 pieces
- Distribution
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- Lot, serial or model codes
- Product Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);
- 510(k) numbers
- ["K101937"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28