Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.
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 addresses a risk of patient infection (a high-risk hazard) without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Ultrasound Endoscopes, including Model GF-UM130, to update the Instructions For Use (IFU). The recall involves adding a new inspection step to the cleaning and disinfection section of the IFU.
The purpose of this update is to reduce the risk of causing patient infections. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
The recall covers 373 devices of the specific model mentioned in the product name, with a broader distribution pattern listing quantities for various related Olympus endoscope models. Users should refer to the updated Instructions For Use for the new inspection step.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 373
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)
- All Serial/Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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