Olympus MAJ-209 Single Use Suction Valves Recalled for Potential Malfunction
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for mechanical failure (valve coming apart or getting stuck) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus MAJ-209 Single Use Suction Valves. These devices are designed to be attached to the suction cylinder of compatible endoscopes, including Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes, and pleurascopes, to aspirate fluid from the distal end of the endoscopes through the instrument channel.
The recall is being issued because there is a potential for the single-use suction valve to come apart and/or remain stuck inside the endoscope. The affected lot numbers are 88H, 89H, 8XH, 8YH, 8ZH, and 91H. Approximately 310,000 units were distributed nationwide in the United States.
Healthcare providers and facilities should stop using these valves and contact Olympus Corporation of the Americas for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 310,000
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 (6)
- Lot numbers: 88H
- 89H
- 8XH
- 8YH
- 8ZH
- 91H
Distribution
Distributed nationwide across the United States.
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