FDA-Device2024-11-06Class II
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Hazard
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Sold states
US Nationwide distribution.
Affected count
445 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2025More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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