Allergan Natrelle Breast Implant Recall for Unreadable 2D Barcodes
Allergan is recalling Natrelle saline-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 indicates a low risk of adverse health consequences. The issue is a documentation and labeling defect (unreadable barcodes) rather than a direct physical hazard to the patient.
Plain-English summary
Allergan PLC is recalling Natrelle saline-filled breast implants and sizers. The recall is due to a defect in the 2D barcodes on the devices, which may be unreadable by GS-1 configured scanners.
The issue stems from the presence of group separators between fixed-length element strings in the UDI data chain, which are not formatted to the GS1 standard. This formatting error prevents proper scanning of the Unique Device Identification (UDI) data.
The recall affects specific styles and sizes of Natrelle saline-filled breast implants, including Style LP, Style 68 HP, and Style 68 MP. The source text does not specify the number of affected units, specific distribution dates, or reported injuries. Consumers and healthcare providers should verify the UDI codes on their devices against the recall list and contact Allergan or their healthcare provider for further instructions.
The recalled product
- Product
- Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline…
- 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Allergan PLC
See all →- ModerateAllergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions
FDA (Devices) · 2021-02-10
- ModerateAllergan Recalls Refresh Relieva Preservative-Free Eye Drops for Missing Labeling
FDA (Drugs) · 2021-01-27
- LowAllergan Recalls Skin Medica Acne System Kits for Subpotency
FDA (Drugs) · 2020-08-05
- ModerateAllergan Recalls Subpotent Skin Medica Acne Treatment Lotion
FDA (Drugs) · 2020-08-05
- LowAllergan Recalls Breast Implants With Non-Standard 2D Barcodes
FDA (Devices) · 2019-12-25
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereAllergan Recalls Natrelle Textured Breast Implants Due to Lymphoma Risk
FDA (Devices) · 2019-09-18
- CriticalAllergan Recalls Textured Breast Implants Due to Lymphoma Risk
FDA (Devices) · 2019-09-18
- ModerateAllergan Recalls Expired Natrelle Breast Implant Sizers
FDA (Devices) · 2015-07-15
- SevereAllergan Recalls Natrelle Tissue Expanders Due to Lymphoma Risk
FDA (Devices) · 2019-09-18
- SevereAllergan Recalls Natrelle Textured Breast Implants and Tissue Expanders
FDA (Devices) · 2019-09-18
- CriticalAllergan Natrelle Tissue Expanders Recalled for Lymphoma Risk
FDA (Devices) · 2019-09-18