Product Wiki · Recalls · U.S. FDA — Device Enforcement

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) — recall Z-1457-2022

U.S. FDA — Device Enforcement · United States · 2022-06-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1457-2022
Date of alert
2022-06-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Davol, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741010118
Reported risk: The device may potentially cause a fire, leading to a safety risk.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.