Recall archive / FDA device enforcement
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. — FDA record Z-0026-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- Reason
- Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Classification
- Class II
- Recalling firm
- Aesculap AG
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0026-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 8, 2025
- Recall initiation date
- Aug 18, 2025
- Center classification date
- Oct 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.