Olympus Endoscopic Flushing Pump Recalled Due to Function Loss
Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall concerns a medical device used in invasive endoscopic procedures. Intermittent loss of function of the flushing pump during such procedures poses a potential risk of harm. However, no injuries or hospitalizations have been reported, and the defect was identified during product testing rather than in clinical use.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus OFP-2 Endoscopic Flushing Pump due to an intermittent loss of function caused by internal component connection failure. The problem was identified during product testing.
Approximately 445 units were affected and distributed nationwide. The device carries UDI-DI 15019778003191. Affected units are identified by specific serial numbers documented in the FDA recall notice.
For detailed information on this recall, including a list of affected serial numbers and recommended actions, refer to the official FDA notification (recall number Z-0229-2025).
The recalled product
- Product
- Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 445
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15019778003191
Distribution
Distributed nationwide across the United States.
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