Olympus MAJ-1606 Instrument Channel Adaptors Recalled for Sterility Breach
Olympus is recalling MAJ-1606 Instrument Channel Adaptors due to small puncture marks in sterile packaging that may compromise sterility.
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 sterility breach (puncture marks in packaging). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling the MAJ-1606 Instrument Channel Adaptor. This single-use adapter connects an endoscope's instrument channel port to the O FP-2 pump's tubing. The recall involves 31,060 units distributed in the United States and Canada.
The recall was initiated because small puncture marks were found in the sterile packaging of the accessories. These marks may indicate a breach in the sterile barrier, potentially compromising the sterility of the device.
The affected products are identified by part numbers K10016901 (packages of 10) and K10007072 (packages of 100). Both part numbers are associated with lot numbers 20115441 and 20116536. Users should stop using these devices and contact Olympus for further instructions.
The recalled product
- Product
- MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 31,060
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)
- Models: Part number K10016901 is a package of 10 pieces
- 20116536
- Part number K10007072: lot numbers 20115441
Distribution
Distributed nationwide across the United States.
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