AESCULAP GB943RRecalls & reported problems
Aesculap AG · ELAN 4 FIXED DURAGUARD LONG · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Aug 18, 2025Open, Classified
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Z-0027-2026 · Root cause: Process control · Recall details · FDA record ↗
Other MOTOR, DRILL, PNEUMATIC devices
- NA 05.001.080Synthes GmbH · MOTOR, DRILL, PNEUMATIC432 reports
- NA CSR60Synthes GmbH · MOTOR, DRILL, PNEUMATIC221 reports
- Midas Rex® AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC163 reports
- Maestro Air 5407-200-000Stryker Corporation · MOTOR, DRILL, PNEUMATIC112 reports
- Maestro 5400210060Stryker Corporation · MOTOR, DRILL, PNEUMATIC95 reports
- MIDAS REX™ AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC91 reports
- CORE, Maestro 5400200000Stryker Corporation · MOTOR, DRILL, PNEUMATIC75 reports
- Maestro Air 5407-200-00HStryker Corporation · MOTOR, DRILL, PNEUMATIC56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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