Z-0027-2026Class II

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R

Name: Z-0027-2026 AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R
Creator: Aesculap AG
Published: 2025-08-18
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2025-08-18 / Open, Classified / root cause: manufacturing process

FDA source

Aesculap AG began a recall of AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R on 2025-08-18. FDA classified it as Class II and gives the reason as "Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0027-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-18
Posted: 2025-10-02
Recalling firm: Aesculap Inc
Product: AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Product code: HBB Motor, Drill, Pneumatic
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."
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Asculap 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:[email protected].
Quantity in commerce: 3 units
Distribution: 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.
Product codes and lots: Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0026-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02
Z-0027-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02

Product code HBB

K172907Class IIELAN 4 Air Motor SystemAesculap, Inc. / cleared 2018-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)