Z-1837-2021Class II

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R -

Name: Z-1837-2021 SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R -
Creator: Sunstar Americas, Inc.
Published: 2021-05-21
License: https://open.fda.gov/license/

Sunstar Americas, Inc. / initiated 2021-05-21 / Terminated

FDA source

Sunstar Americas, Inc. began a recall of 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... on 2021-05-21. FDA classified it as Class II and gives the reason as "Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1837-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-21
Posted: 2021-06-09
Terminated: 2024-09-04
Recalling firm: Sunstar Americas, Inc.
Product: 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 code: NTO Rinse, Oral, Antibacterial (By Physical Means)
Reason for recall: Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 05/21/2021. The firm is requesting the return of the product and has directed the distributors to notify their customers.
Quantity in commerce: 124064 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Mexico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1837-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1837-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code NTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)