Z-0113-2016Class II

MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's...

Name: Z-0113-2016 MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's...
Creator: Olympus Corporation of the Americas
Published: 2015-09-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2015-09-11 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2015-09-11. FDA classified it as Class II and gives the reason as "small puncture marks in a sterile package for an accessory to an Olympus device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0113-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Posted: 2015-10-08
Terminated: 2017-03-13
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: FEQ Pump, Air, Non-Manual, For Endoscope
Reason for recall: small puncture marks in a sterile package for an accessory to an Olympus device
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.
Quantity in commerce: 31060
Distribution: US (nationwide) and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-08

Product code FEQ

K100899Class IIOlympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd. / cleared 2010-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)