Sunstar Perioshield Oral Rinse Recall: Microbial Contamination Risk
Sunstar recalls Perioshield oral rinse due to potential contamination with Burkholderia bacteria. Affected SKUs include 1775P and 1775R with specific lot numbers. Consumers should check their product details to determine if recalled.
Lower-risk recall
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Contact the company
What happened, in plain English
Sunstar is recalling its Perioshield oral rinse product due to possible contamination with harmful bacteria. This could lead to infections or health issues, especially for people with weakened immune systems or existing dental conditions. Read more at govinfonow.com/recall/62494-sunstar-perioshield-oral-rinse-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62494-sunstar-perioshield-oral-rinse-recall-microbial-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1837-2021
Cite this page
“Sunstar Perioshield Oral Rinse Recall: Microbial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62494-sunstar-perioshield-oral-rinse-recall-microbial-contamination-risk. Based on FDA recall #Z-1837-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1837-2021%22&limit=1).
Why it’s dangerous
The rinse may contain harmful bacteria, Burkholderia cepacia and/or Burkholderia contaminans, which can cause infections. These bacteria are typically found in soil and water, but contamination in the rinse product poses a health risk if ingested.
Who’s affected
People who own or use the recalled Perioshield oral rinse (SKU 1775P or 1775R) with specific lot numbers are affected. Those with compromised immune systems or dental issues may be at higher risk.
How to tell if you have this one
Check the SKU number on the product label: 1775P or 1775R. Look for specific lot numbers listed: 01U, 02U, 03U, 01Z, 02Z, 03Z, 04Z, 05Z, 01A, 02A, 01B, 02B, 3B.
- Brand
Sunstar- Category
Medical device
What to do — step by step
Check Product Details
Identify your SKU number (1775P or 1775R) and lot numbers to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Mexico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states the product may be contaminated with harmful bacteria, so it is not recommended for use until confirmed safe.
What should I do if I have the recalled product?
Check your SKU and lot numbers to see if it's affected. If it is, stop using it and contact Sunstar for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1837-2021 (May 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1837-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.