Olympus Single Use Distal Cover MAJ-2315 Duodenovideoscope Replacement
Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The source text provides no specific hazard description or adverse event information, only that a newly designed version is being released to replace the previous design, suggesting a design improvement or precautionary replacement.
Plain-English summary
Olympus Corporation of the Americas has developed and released a newly designed version of the Olympus Single Use Distal Cover, Catalog Number MAJ-2315. This cover is designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator.
The previous design of the Single Use Distal Covers is being replaced by this new design. Approximately 988,700 units were distributed nationwide. The recalled product is identified by UDI/DI 04953170441271 and Lot Numbers H2530 or later.
Patients and healthcare providers using the previous version of the MAJ-2315 Distal Cover should replace it with the newly designed version. For more information or questions, contact Olympus Corporation of the Americas.
The recalled product
- Product
- Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories…
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 988,700
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)
- UDI/DI: 04953170441271
- Lot Numbers: H2530 or later
Distribution
Distributed nationwide across the United States.
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