Allergan Recalls Breast Implant Sizers Due to Unreadable Barcodes
Allergan is recalling NATRELLE Resterilizable Sizers because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect (barcode formatting) with no reported injuries.
Plain-English summary
Allergan PLC is recalling NATRELLE Resterilizable Sizers for various styles and sizes, including Style 15, Style 20, and multiple Inspira gel models. The recall affects units distributed across numerous US states and territories.
The firm became aware that the 2D barcodes on these sizers may be unreadable by GS-1 configured scanners. This issue arises because the barcodes contain group separators between fixed-length element strings in the UDI data chain that are not formatted to the GS1 standard.
No illnesses or injuries have been reported in connection with this recall. The issue is limited to the readability of the identification barcodes.
The recalled product
- Product
- NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch…
- Manufacturer
- Allergan PLC
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 recalled by Allergan PLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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