Sunstar G.U.M Perioshield Oral Rinse Recalled Due to Bacterial Contamination
Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for microbial contamination with Burkholderia species. While these organisms present potential health risks, particularly to vulnerable populations, no illnesses or injuries are reported in the source. The score reflects the serious nature of bacterial contamination in a product intended for oral use without confirmed cases of harm.
Plain-English summary
Sunstar Americas, Inc. is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, a 300mL oral care product designed to help prevent and treat gingivitis. The affected products have SKU numbers 1775P and 1775R and are identified by specific lot numbers.
The products have been found to be contaminated with the bacteria Burkholderia cepacia and/or Burkholderia contaminans. These microorganisms may pose health risks to consumers using the product.
Approximately 124,064 units have been distributed worldwide, including throughout the United States and Mexico. Consumers who purchased this product should check their packaging for the applicable lot numbers identified in the official recall notice.
If you have this product, discontinue use immediately. Verify the product's lot number against the recall notice to determine if it is affected. Contact Sunstar Americas or the FDA for instructions on returning or disposing of the product safely. Speak with a healthcare provider if you have any health concerns related to use of this product.
The recalled product
- 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.
- Manufacturer
- Sunstar Americas, Inc.
- Category
- Medical Device — Oral Care
- Hazard
- bacterial-contamination
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 (15)
- SKU number 1775P
- Lot Numbers: 01U
- 02U
- 03U
- 01Z
- 02Z
- 03Z
- 04Z
- 05Z
- 01A
- 02A
- 01B
- 02B
- 3B SKU number 1775R
- 3B
Distribution
Distributed nationwide across the United States.
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