HIGH

Aesculap ELAN 4 Fixed Duraguard Recalled for Mislabeling (1 Unit, 2025)

Aesculap AG is recalling one unit of the ELAN 4 Fixed Duraguard Standard, model GB942R, distributed in the United States to Missouri and internationally to multiple countries. The recall addresses mislabeling where the Standard was labeled as Long and the Long was labeled as Standard. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall指南

Quick Facts at a Glance

Recall Date
August 18, 2025
Hazard Level
HIGH
Brand
Aesculap AG
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aesculap AG or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The ELAN 4 Fixed Duraguard is a medical device used in surgical contexts requiring a fixed Duraguard configuration.

Why This Is Dangerous

Mislabeling between Long and Standard variants could lead to incorrect device selection during procedures.

Industry Context

This recall is not indicated as part of a broader industry pattern.

Real-World Impact

Clinicians must verify device labeling to avoid incorrect instrument configuration; potential impact on procedure planning and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check device labeling for GB942R and alternate BG942R
  2. Verify against UDI-DI 04046963805777 and Serial Number 8157
  3. Compare labeling with documentation and packaging

Where to find product info

UDI label on packaging and device documentation; recall notice provides guidance

What timeline to expect

Refunds or replacements typically processed within 4-8 weeks

If the manufacturer is unresponsive

  • Escalate to regulatory bodies if the manufacturer is slow to respond
  • Maintain records of all correspondence and recall notices

How to prevent similar issues

  • Verify labeling accuracy during procurement
  • Confirm UDI numbers and model during device selection
  • Train staff to check for mislabeling before use

Documentation advice

Keep recall notices, emails, serial numbers, photos, and correspondence

Product Details

Model: GB942R (also listed as BG942R in some records). Distribution: US to Missouri; International distribution to Norway, Portugal, France, United Kingdom, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand. Quantity: 1 unit. Sold/used date and price not specified.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model GB942R / BG942R
  • Distribution US (Missouri) and international markets
  • Hazard: mislabeling between 'Long' and 'Standard'
  • Status: Active recall as of 2025-10-08

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
GB942R
BG942R
Report Date
October 8, 2025
Recall Status
ACTIVE

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