CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

Sunstar G.U.M Perioshield Oral Health Rinse recalled by Sunstar Americas

Sunstar Americas is recalling Sunstar G.U.M Perioshield Oral Health Rinse, distributed nationwide in the US. The recall was initiated on 21 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSKU 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

Quantity recalled124064 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1837-2021
FDA event ID: 87976
Recalling firm: Sunstar Americas, Schaumburg, IL
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2021
FDA classified: 9 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

21 May 2021	Recall initiated by company
9 Jun 2021	Classified by FDA	+19 days
16 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Sunstar G.U.M Perioshield Oral Health Rinse recalled?

Yes. Sunstar Americas recalled Sunstar G.U.M Perioshield Oral Health Rinse on 21 May 2021. The recall is Class II and its status is Terminated. Recall number Z-1837-2021.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sunstar Americas

All 6

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022Device	CLASS II	Butler Clear Dip/case recalled by Sunstar Americas	Sunstar Americas	Other	Nationwide
21 Apr 2021Device	CLASS II	Sunstar Butler Clear Dip recalled by Sunstar Americas	Sunstar Americas	Sterility	IL
17 Mar 2021Device	CLASS II	Sunstar G.u.m recalled by Sunstar Americas	Sunstar Americas	Sterility	Nationwide
20 Jan 2021Drug	CLASS II	Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 12%, Alcohol Free recalled	Sunstar Americas	Sterility	Nationwide
2 Dec 2020Drug	CLASS I	Paroex (chlorhexidine gluconate) Oral Rinse, USP 12%, Alcohol Free recalled	Sunstar Americas	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide