SA3 Silatrix Oral Gel Recall: Microbial Testing Failure
SA3 recalls Silatrix Oral Gel 10% due to microbial testing failure. Affected units may contain harmful bacteria. Consumers should contact SA3 for details.
Recall notice
Due to failure of microbial testing for total aerobic microbial count (TAMC).
Contact the company
What happened, in plain English
SA3 is recalling Silatrix Oral Gel 10% because microbial testing failed, potentially allowing harmful bacteria to grow. This could cause health issues if used without proper testing. Read more at govinfonow.com/recall/61122-sa3-silatrix-oral-gel-recall-microbial-testing-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/61122-sa3-silatrix-oral-gel-recall-microbial-testing-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0856-2022
Cite this page
“SA3 Silatrix Oral Gel Recall: Microbial Testing Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61122-sa3-silatrix-oral-gel-recall-microbial-testing-failure. Based on FDA recall #Z-0856-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0856-2022%22&limit=1).
Why it’s dangerous
The gel failed microbial testing for total aerobic microbial count, meaning harmful bacteria could grow in the product. This poses a risk of infection or other health problems if the gel is ingested.
Who’s affected
People who use Silatrix Oral Gel 10% for medical purposes are affected. Those with compromised immune systems may be at higher risk.
How to tell if you have this one
Check for Product Number 69420-8351-1 and Lot Number U701SF1 on the packaging. The gel is sold under the brand name Silatrix Oral Gel 10%.
- Brand
SA3- Category
Medical device
What to do — step by step
Contact SA3
Reach out to SA3 directly for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA, FL and GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia.
Recall timeline
FDA terminated this recall 2.2 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.
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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-0856-2022 (February 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0856-2022 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.