FDA Device Recall Z-0026-2026: Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0026-2026.

Recall Res Number

Z-0026-2026

Recalling Firm / Manufacturer

Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany

FEI Number

3002806315

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-08-18

Date Posted

2025-10-02

Date Terminated

N/A

Product Code

HBB

Event Number

97507

Product Quantity

1 unit

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

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."

Action Details 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:allison.longenhagen@bbraunusa.com.

Distribution Pattern 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.

Code Information / Serial Numbers Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.

Related Establishments / Registrations

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THE ANSPACH EFFORT, INC. Registration: 1045834 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
MEDTRONIC POWERED SURGICAL SOLUTIONS Registration: 1625507 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO Registration: 2647346 View Registration
STERIS ISOMEDIX PUERTO RICO, INC. Registration: 2648623 View Registration
AESCULAP, INC. Registration: 2916714 View Registration
Synthes GMBH Registration: 3000270450 View Registration
3D MEDICAL MANUFACTURING, INC. (dba Tecomet) Registration: 3001239363 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
Vaupell Midwest Molding and Tooling Registration: 3003595343 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
Kimball Electronics - Indianapolis Registration: 3004598644 View Registration
COMMAND MEDICAL NICARAGUA SA Registration: 3005382983 View Registration
ADEOR MEDICAL AG Registration: 3007031059 View Registration
STRYKER MANUFACTURING KALAMAZOO Registration: 3007997036 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
SYNTHES GMBH Registration: 3009417901 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010155648 View Registration
Synergy Health Westport Ltd Registration: 3010173425 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Stryker Instruments Registration: 3015967359 View Registration
ZETHON LTD Registration: 3016172274 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
Stryker Ireland Ltd. Instruments Division, Innovation Centre Registration: 3040335671 View Registration
SYNTHES GMBH / Synthes Produktions GmbH Registration: 8030965 View Registration
AESCULAP AG Registration: 9610612 View Registration
STRYKER IRELAND LTD., INSTRUMENTS DIVISION Registration: 9616696 View Registration

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Medical Device Recall: Z-0026-2026

Recall Parameters & Description

Related Establishments / Registrations

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