Data Foundry

Medical device recalls 2013

Olympus Endoscopic Flushing Pump — Class II medical device recall Z-0329-2014

Terminated recall by Olympus America Inc., reported 2013-11-27, distributed nationwide. There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an un

Recall numberZ-0329-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOlympus America Inc., Center Valley, PA, United States
Recall initiated2013-05-20
Classified2013-11-15
Reported by FDA2013-11-27
Terminated2016-10-24
DistributedNationwide (US)
Countries outside the USCA
Quantity263
Serial numbers21220168, 21220169, 21220170, 21220171, 21220172, 21220174, 21220175, 21220176, 21220178, 21220179, 21220180, 21220181, 21220260, 21220262, 21220263, 21220357, 21220358, 21220613, 21220614, 21220615, 21220616, 21220618, 21220620, 21220621, 21220623 and 213 more
Model numbersOPF-2

Product

Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.

Reason for recall

There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0329-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.