ConMed Linvatec Recalls Xenon Universal Light Source Devices
ConMed Linvatec is recalling 57 Xenon Universal Light Source units used for endoscopic illumination due to a Class II recall.
What this means for you
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, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source does not report specific injuries or deaths, placing it in the High severity category.
Plain-English summary
Linvatec Corporation dba ConMed Linvatec has initiated a recall of 57 units of the LS7700 Xenon Universal Light Source. These devices are intended to be used with an endoscope to provide illumination during endoscopic procedures.
The recall covers units distributed worldwide, including the United States, Canada, Denmark, Hong Kong, India, Italy, South Korea, Malaysia, Russia, Colombia, Vietnam, and South Africa. The agency has classified this as a Class II recall.
The source text does not specify the exact nature of the defect or the specific health hazards associated with the use of these devices. Consumers and healthcare providers should contact the recalling firm for further instructions on how to proceed with the recall.
The recalled product
- Product
- ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 57
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)
- GCT
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Linvatec Corp. dba ConMed Linvatec 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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