Fujifilm Medical Systems Recalls Duodenoscopes for Reprocessing Design Changes
Fujifilm Medical Systems is recalling specific duodenoscope models as a precautionary measure because the devices have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text explicitly describes the recall as a 'precautionary measure' and does not report any illnesses, injuries, or deaths, which aligns with the rubric criteria for a Moderate severity score (voluntary precautionary recalls).
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling specific models of Duodenoscopes, including the ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. These are medical endoscopes used for the duodenum and upper gastrointestinal tract that feature an open elevator wire channel. The recall involves 79 units in the United States and 985 units internationally.
The recall is a precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. The affected units were distributed in the United States to California, Colorado, Florida, Iowa, Illinois, Kansas, Louisiana, Maryland, Minnesota, Missouri, North Carolina, Tennessee, and Washington, as well as internationally to the Asian Pacific, EU, Latin America, and Japan.
Healthcare facilities and consumers should check their inventory for the specific model and serial numbers listed in the recall notice. If a device is affected, it should be removed from service and returned to Fujifilm Medical Systems U.S.A., Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Hazard
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 (19)
- Model Number: ED-200XU: Serial Numbers: 6572042
- 2D071D016
- 2D071D010
- 2D071D029 and 2D071D026 Model Number: ED-410XT: Serial Numbers: 8691039
- 8691034 and 7691022 Model Number: ED-410XU: Serial Numbers: 2D060D010
- 2D060D003
- 6602091 and 6602100 Model Number: ED-450XL: Serial Numbers: 6D075B023
- 6D075B015
- 1D075B029 and 6D075B020 Model Number: ED-450XT: Serial Numbers
- 1D076A002
- 1D076A011
- 1D076A013
- 1D076A043
- 1D076A039
- 6D076A020
- 6D076A033
- 6D076A039
- 6D076A037
- 6D076A030 and 6D076A051
Distribution
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