CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report

Elan 4 Fixed Duraguard Standard recalled by Aesculap AG

Aesculap is recalling Elan 4 Fixed Duraguard Standard, distributed in Missouri. The recall was initiated on 18 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0026-2026
FDA event ID: 97507
Recalling firm: Aesculap, Tuttlingen, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 18 Aug 2025
FDA classified: 2 Oct 2025
Reported: 8 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

18 Aug 2025	Recall initiated by company
2 Oct 2025	Classified by FDA	+45 days
8 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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."

Product as listed by the FDA

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

Where it was distributed

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.

Missouri

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97507

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025	CLASS II	Elan 4 Fixed Duraguard Long recalled by Aesculap AG	Aesculap	Labeling Errors	MO

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