Data Foundry

Medical device recalls 2024

Olympus Endoscopic Flushing Pump — Class II medical device recall Z-0229-2025

Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-06, distributed nationwide. During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused

Recall numberZ-0229-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmOlympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated2024-08-23
Classified2024-10-25
Reported by FDA2024-11-06
DistributedNationwide (US)
Quantity445 units
UPC / GTIN / UDI-DI15019778003191
Serial numbers22324536, 22324666, 22324667, 22324668, 22324681, 22324815, 22324816, 22324817, 22324837, 22324838, 22324922, 22324923, 22324931, 22324932, 22325005, 22325008, 22325205, 22325207, 22325208, 22325303, 22325304, 22325305, 22325306, 22325315, 22325316 and 420 more
Model numbersOFP-2

Product

Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

Reason for recall

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

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-0229-2025. 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.