The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0856-2022·Announced 2022-04-13

Oral gel recalled for failed microbial testing

SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall based on failed microbial testing. This is a precautionary recall initiated due to testing failure without reported illnesses or injuries, matching the rubric criterion for moderate-severity voluntary precautionary recalls.

Plain-English summary

SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm) due to failure of microbial testing for total aerobic microbial count (TAMC). The recalled product, Lot Number U701SF1 (Product Number 69420-8351-1), was distributed nationwide in California, Florida, and Georgia.

The product failed testing for total aerobic microbial count, a standard safety test for oral products. This testing failure prompted the recall.

Consumers who have purchased this product should not use it. Contact your healthcare provider or SA3, LLC for instructions on returning the product.

The recalled product

Product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Manufacturer
SA3, LLC
Category
Medical Device — Oral Care
Hazard
Affected units
156

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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