The Recall Desk
HighFDA (Devices)·Z-1457-2022·Announced 2022-08-03

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.

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: 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.
Category
Medical Device — Surgical Irrigation System
Hazard

Distribution

Distributed nationwide across the United States.

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