Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Reported: November 27, 2013 Initiated: September 20, 2013 #Z-0361-2014
Product Description
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Reason for Recall
The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 30
- Distribution
- Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US). Recalled by Aesculap, Inc.. Units affected: 30.
Why was this product recalled? ▼
The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0361-2014.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11