PlainRecalls
FDA Devices Moderate Class II Ongoing

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

Reported: August 3, 2022 Initiated: June 27, 2022 #Z-1457-2022

Product Description

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

Reason for Recall

The device may potentially cause a fire, leading to a safety risk.

Details

Recalling Firm
Davol, Inc.
Units Affected
9420 (9337 in US; 83 OUS)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Location
Warwick, RI

Frequently Asked Questions

What product was recalled?
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000). Recalled by Davol, Inc.. Units affected: 9420 (9337 in US; 83 OUS).
Why was this product recalled?
The device may potentially cause a fire, leading to a safety risk.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1457-2022.