Recall Z-0229-2025— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-08-23. It names one FDA 510(k) clearance: K100899. Product: Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141). Reason: During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-23
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.