Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Reported: June 8, 2016 Initiated: December 23, 2015 #Z-1864-2016
Product Description
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Reason for Recall
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 94 units
- Distribution
- Nationwide Distribution.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 94 units.
Why was this product recalled? ▼
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1864-2016.
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