FDA Device recall Z-1837-2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p…
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p… by Sunstar Americas, citing products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1837-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-21 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sunstar Americas |
| Distribution | US |
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.
Reason
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Identifiers
| code_info | SKU number 1775P, Lot Numbers: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B , 3B SKU number 1775R, Lot…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Sunstar Americas
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FDA Device · Class II · 2022-03-09 · Sunstar Americas - SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Device · Class II · 2021-04-21 · Sunstar Americas - 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 formulated with wat…
FDA Device · Class II · 2021-03-17 · Sunstar Americas - Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02
FDA Drug · Class II · 2021-01-20 · Sunstar Americas - Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02
FDA Drug · Class I · 2020-12-02 · Sunstar Americas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1837-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.