Allergan Recalls Breast Implants With Non-Standard 2D Barcodes
Allergan is recalling Natrelle Inspira silicone-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.
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 and scanning defect rather than a direct physical hazard.
Plain-English summary
Allergan PLC is recalling specific styles and sizes of Natrelle Inspira silicone-filled breast implants. The recall is due to a defect in the 2D barcodes located on the implants and sizers.
The 2D barcodes contain group separators between fixed-length element strings in the UDI data chain that are not formatted to the GS1 standard. As a result, these barcodes may be unreadable by GS-1 configured scanners.
The affected products were distributed to various states and territories in the United States. The source text does not specify the number of affected units or report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US)…
- Manufacturer
- Allergan PLC
- Category
- Medical Device — Breast Implants
- 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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