Sunstar Americas, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1837-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

Product Classification:

Class II

Date Initiated: May 21, 2021

Date Posted: June 16, 2021

Recall Number: Z-1837-2021

Event ID: 87976

Reason for Recall:

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

Status: Terminated

Product Quantity: 124064 units

Code Information:

SKU number 1775P, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B SKU number 1775R, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the country of Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated