Olympus Corporation of the Americas: Medical Device Recall in 2015 - (Recall #: Z-0113-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 11, 2015

Date Posted: October 14, 2015

Recall Number: Z-0113-2016

Event ID: 72242

Reason for Recall:

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

Status: Terminated

Product Quantity: 31060

Code Information:

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

Distribution Pattern:

US (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated