Olympus TJF-Q180V Duodenoscope Recall for Forceps Elevator Mechanism Replacement
Olympus is voluntarily removing all TJF-Q180V duodenoscopes to replace the forceps elevator mechanism with a new design consistent with recent 510(k) specifications.
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 recall is classified as FDA Class II and is a voluntary corrective action to replace a mechanism with a design consistent with recent specifications. There are no reported injuries, illnesses, or deaths in the source text, and the hazard is theoretical/precautionary, fitting the Moderate criteria for voluntary precautionary recalls.
Plain-English summary
Olympus Corporation of the Americas is conducting a voluntary removal and corrective action for all TJF-Q180V flexible gastrointestinal duodenoscopes. The recall involves replacing the forceps elevator mechanism with a new design that aligns with the design specifications in the recently cleared TJF-Q180V 510(k).
The affected products are distributed nationwide in the United States, excluding Puerto Rico. The recall covers 4,436 units. This action is taken to ensure the instrument meets the current design specifications for use with Olympus video systems and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Healthcare facilities and users should contact Olympus Corporation of the Americas for instructions on how to replace the forceps elevator mechanism. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 4,436
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 codes
Distribution
Distributed nationwide across the United States.
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