# FDA recall Z-0026-2026

> **Aesculap AG** · Class II · device recall initiated 2025-08-18.

## Product

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

## Reason for recall

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

## 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.

## Key facts

- **Recall number:** Z-0026-2026
- **Recalling firm:** Aesculap AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-18
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tuttlingen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2026

## Citation

> AI Analytics. FDA recall Z-0026-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0026-2026. Source: US FDA. Licensed CC0.

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