Fujifilm Medical Endoscope Manuals Recalled Due to Suction Button Defect
Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.
What this means for you
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 recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. No injuries or illnesses are reported in the source text, and the issue is a mechanical defect (stuck button) rather than a high-risk pathogen or structural failure leading to immediate severe harm.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 256 units of operation manuals for specific Fujifilm Medical Endoscopes used for the duodenum and upper G.I. tract. The affected models include the ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5. These manuals were distributed in the United States and Canada.
The recall is being conducted because the suction button on the ED-530XT endoscope may become lodged in the active position following the use of x-ray contrast agents during ERCP procedures. This defect is associated with the operation manuals for the listed endoscope models.
Healthcare facilities and users who possess these specific operation manuals should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to handle the affected documentation.
The recalled product
- Product
- Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscopes
- Hazard
- Affected units
- 256
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 (3)
- ED-530XT - Part #202B1237697D
- ED-250XT5 and ED-250XL5 - Part #202B1260196A
- ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681
Distribution
Distribution scope not specified by the agency.
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