Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures
Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection 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 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 involves the implementation of revised reprocessing procedures without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Olympus America Inc. is recalling 6,109 units of the EVIS EXERA II Duodenovideoscope, model TJF-Q180V. The recall is being conducted to issue new and validated reprocessing procedures for the device.
The recall involves the implementation of revised manual cleaning and high-level disinfection procedures. The affected instruments are designed for endoscopy and endoscopic surgery within the duodenum and are used with Olympus video systems and ancillary equipment.
The recall covers units distributed nationwide in the United States, as well as in Canada and Mexico. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for…
- Manufacturer
- Olympus America Inc.
- Category
- Medical Device — Endoscopy
- Affected units
- 6,109
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 (2)
- Model: TJF-Q180V
- all sold units
Distribution
Distributed nationwide across the United States.
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