Fujifilm Endoscope Corrective Action Following FDA Inspection
Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.
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 describes a corrective action following an FDA inspection without specifying a defect, injury, or specific hazard, aligning with the rubric for voluntary precautionary actions or minor issues where risk is not explicitly detailed.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for Fujifilm Endoscopes, specifically models ED-250XL5, ED-250XT5, ED-450XT5, and ED-450XL5. These medical devices are intended for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
The corrective action is being conducted due to an FDA inspection. The source text does not specify the exact nature of the defect, the specific hazards associated with the inspection findings, or the number of affected units beyond the 260 manuals mentioned in the product metadata. Distribution was nationwide in the United States.
Consumers and healthcare providers should refer to the official FDA recall notice for specific instructions on how to proceed with the corrective action.
The recalled product
- Product
- Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 260
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)
- will be entered.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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