FDAClass IIOctober 14, 2015

MAJ-1606 Instrument Channel Adaptor recall

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…

Why was MAJ-1606 Instrument Channel Adaptor recalled?

small puncture marks in a sterile package for an accessory to an Olympus device

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536

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…
Recalling firm
Olympus Corporation of the Americas
Quantity
31060
Distribution
US (nationwide) and Canada.
Recall date
October 14, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls