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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateFujifilm Medical Endoscope Manuals Recalled Due to Suction Button Defect
FDA (Devices) · 2015-09-23
- ModerateFujifilm Endoscope Corrective Action Following FDA Inspection
FDA (Devices) · 2017-09-20
- ModerateFujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications
FDA (Devices) · 2015-09-30
- LowFujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection
FDA (Devices) · 2017-09-20
- LowFujifilm EPX 2500 Processor Manual and Brochure Recall
FDA (Devices) · 2015-09-30
- HighFujifilm Recalls 362 Fujinon ED-530XT Endoscopes for Reprocessing Risk
FDA (Devices) · 2017-10-04