Sunstar Americas, Inc. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
BUTLER Clear Dip, 12 bottles/caseClass IIJan 14, 2022Product lacks premarket clearance.	Product lacks premarket clearance.	Class IIDevices	Jan 14, 2022
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat ginClass IIMay 21, 2021Products may be contaminated with micro-organisms Burkholder	Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.	Class IIDevices	May 21, 2021
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PAClass IIMar 23, 2021Product may be contaminated with Burkholderia contaminans.	Product may be contaminated with Burkholderia contaminans.	Class IIDevices	Mar 23, 2021
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is Class IIFeb 18, 2021The product may be contaminated with Burkholderia cepacia	The product may be contaminated with Burkholderia cepacia	Class IIDevices	Feb 18, 2021