Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure
Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.
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: The recall is classified as FDA Class II, and the hazard involves a functional failure of a medical device during a procedure. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Olympus America Inc. is recalling 263 units of the Olympus Endoscopic Flushing Pump, Model OPF-2. This device is used to facilitate the washing of tissues to remove blood, feces, and other organic matter during endoscopic procedures. The units were distributed nationwide in the United States and in Canada.
The recall is due to a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position, it may, under certain circumstances, cause the pump to stop and go into power stand-by mode. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users should check their inventory for Model OPF-2 pumps with the specific serial numbers listed in the official recall notice. If a unit is found, it should be removed from service and returned to Olympus America Inc. for repair or replacement according to the company's instructions.
The recalled product
- Product
- Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
- Manufacturer
- Olympus America Inc.
- Affected units
- 263
Distribution
Distributed nationwide across the United States.
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