Medical Device Recall: DeRoyal Breast Augmentation Pack Class II
DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.
What this means for you
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: This is a voluntary Class II recall initiated by the manufacturer. No illnesses, injuries, or deaths are reported in available FDA materials. Voluntary precautionary recalls without reported harm are classified as Moderate severity.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 70 kits of its Breast Augmentation Pack (REF 89-9618.05) under FDA Class II classification. The recall was initiated on November 3, 2022, and remains ongoing.
The specific reason for this recall is not provided in available FDA documentation. The affected product was distributed to healthcare facilities in 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The recalled lot numbers are: Lot 55968916 (expiration 7/1/2023), Lot 56620786 (expiration 7/1/2023), and Lot 56780667 (expiration 7/1/2023). Healthcare providers and individuals should contact DeRoyal Industries Inc or the FDA for further information and instructions regarding the recalled product.
The recalled product
- Product
- DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
- Manufacturer
- DeRoyal Industries Inc
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 (3)
- Lot Numbers: Lot 55968916 exp 7/1/2023
- Lot 56620786 exp7/1/2023
- Lot 56780667 exp 7/1/2023
Distribution
Distribution scope not specified by the agency.
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