X-Stream Irrigation System recalled due to potential fire hazard
Davol, Inc. is recalling the X-Stream Irrigation System due to a potential fire hazard. The device may cause a fire during use, creating a safety risk.
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 is a Class II medical device recall involving a fire hazard. Although no injuries or hospitalizations have been reported and the hazard is characterized as potential rather than confirmed, fire represents a serious risk of harm. This meets the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Davol, Inc. is recalling the X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) due to a fire hazard. The device may potentially cause a fire, which creates a safety risk for users.
The affected devices were distributed in the United States, Canada, and Chile. Approximately 9,420 units are involved in this recall, consisting of 9,337 units in the United States and 83 units outside the United States.
The FDA classified this as a Class II recall. Consumers with this device should contact Davol, Inc. or the FDA for information regarding this recall.
The recalled product
- Product
- X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
- Manufacturer
- Davol, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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