Fujifilm ED-450XL5 Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (endoscope) where injury has not yet been reported in the source text, but the hazard involves high-risk pathogens (multi-drug resistant bacteria).
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is correcting the operation manual for the ED-450XL5 endoscope. The specific document involved is the "Operation Manual: Cleaning, Disinfection and Storage." This correction is being issued in response to publicized reports of multi-drug resistant bacteria found on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The recall covers 94 units of the manual that were distributed nationwide between March 2003 and April 2016. The source text does not specify the exact number of affected endoscopes, only the number of manual units involved in this specific correction action.
Healthcare facilities and users of the ED-450XL5 endoscope should review the corrected manual to ensure they are following the most current cleaning, disinfection, and storage protocols. This action is intended to mitigate the risk of infection associated with the use of these devices.
The recalled product
- Product
- Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Affected units
- 94
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All distribution dates :3/2003-4/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Fujifilm Medical Systems U.S.A., Inc.
See all →- HighSynapse Cardiovascular software may incorrectly reuse patient database identifiers
FDA (Devices) · 2021-06-09
- HighFujifilm Medical Systems Recalls Potentially Defective Wako Chip Cassettes
FDA (Devices) · 2021-04-21
- HighFujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display
FDA (Devices) · 2021-04-14
- ModerateFujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error
FDA (Devices) · 2021-02-03
- ModerateFujifilm Synapse PACS Software Recalled for Clinical Reporting Errors
FDA (Devices) · 2021-02-03
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19