Allergan Recalls Natrelle Breast Implants Due to Unreadable 2D Barcodes
Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.
What this means for you
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 hazard is a documentation and labeling issue (unreadable barcodes) rather than a direct physical or chemical safety risk.
Plain-English summary
Allergan PLC is recalling Natrelle Silicone Filled Breast Implants, including Styles 10, 15, 20, 40, and 45, as well as associated sizers. The recall is due to a defect in the 2D barcodes on the devices, which may be unreadable by scanners configured for the GS-1 standard.
The issue stems from the presence of group separators between fixed-length element strings in the UDI data chain, which are not formatted according to the GS1 standard. This formatting error prevents proper scanning and identification of the devices.
The recall covers distribution across numerous US states and territories, including Alabama, Arizona, California, Florida, New York, and Texas. Consumers and healthcare providers should check their devices for the affected UDI codes and contact their healthcare provider or Allergan for further instructions.
The recalled product
- Product
- Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Roun
- Manufacturer
- Allergan PLC
- Category
- Medical Device — Breast Implants
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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