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U.S. Department of Health and Human Services

Class 2 Device Recall AESCULAP

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 Class 2 Device Recall AESCULAPsee related information
Date Initiated by FirmAugust 18, 2025
Date PostedOctober 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0026-2026
Recall Event ID 97507
510(K)NumberK172907 
Product Classification Motor, drill, pneumatic - Product Code HBB
ProductAESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Code Information Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
FEI Number 3002806315
Recalling Firm/
Manufacturer		 Aesculap AG
Am Aesculap-Platz 1
Tuttlingen Germany
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer 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."
FDA Determined
Cause 2		Process control
ActionAsculap notified consignees with an "Urgent Field Safety Notice" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter. If you have any question, call 484.240.8373 or email:allison.longenhagen@bbraunusa.com.
Quantity in Commerce1 unit
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBB
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