Fujifilm ED-250XL5 Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address 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 involves a medical device manual related to high-risk pathogens (multi-drug resistant bacteria) and infection control, fitting the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 98 units of the Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection. This action is a correction issued in response to publicized reports of multi-drug resistant bacteria found on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The affected manuals were distributed nationwide between March 2003 and April 2016. The recall is classified as Class II by the FDA. The source text does not specify the exact nature of the manual's error or the specific corrective action required beyond the context of the publicized reports.
The recalled product
- Product
- Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Affected units
- 98
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.
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