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  1. FDA Recalls
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FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1–2 of 2 recalls for “Mislabeling”

Class IIOngoing

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

Aesculap AG

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

August 18, 2025 · DeviceView details →
Class IIOngoing

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Aesculap AG

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

August 18, 2025 · DeviceView details →