Aesculap Ag
FDA adverse event reports naming Aesculap Ag as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: AESCULAP AG.
- Total reports
- 5,863
- Deaths
- 14
- Injuries
- 3,996
- Malfunctions
- 1,850
Reports per year
Source: FDA adverse event reports by year received, 1996–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1,306
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI417
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO361
- Clip, ImplantableFZP309
- Orthopedic Manual Surgical InstrumentLXH215
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY213
- Appliance, Fixation, Spinal Intervertebral BodyKWQ202
- Prosthesis, Intervertebral DiscMJO165
- Knee Arthroplasty Implantation SystemOOG149
- Thoracolumbosacral Pedicle Screw SystemNKB141
Recent recalls
- 2025-10-02Open, ClassifiedProcess control
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- 2025-10-02Open, ClassifiedProcess control
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
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