AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R recallZ-0027-2026 · Aesculap AG · initiated Aug 18, 2025
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 AG 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
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
FDA root cause category: Process control
What the company is doing
Asculap notified consignees with an "Urgent Field Safety Notice" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter. If you have any question, call 484.240.8373 or email:[email protected].
Recall details
- Recall number
- Z-0027-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2025
- Posted by the FDA
- Oct 2, 2025
- Recalling firm
- Aesculap AG
- Quantity
- 3 units
- Product code
- HBB
- FDA submissions
- K172907
- Distribution
- US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.
Product description
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Code information (models, lots, serial numbers)
Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AESCULAP GB943RAesculap AG · MOTOR, DRILL, PNEUMATIC1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97507).
- Z-0026-2026 · Open, ClassifiedAESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
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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