Reported Dec 25, 2019 · Terminated

Natrelle Silicone Filled Breast Implants for the following Styles and Sizes

Allergan PLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531

Is this the product you have?

Natrelle Silicone Filled Breast Implants for the following Styles and Sizes

66 of 66 products

Products covered by this recall
Model / numberProduct as published
10888628001206Natrelle 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
10888628001213NATRELLE Style 10-210 Gel Round Mod
10888628001220NATRELLE Style 10-240 Gel Round Mod
10888628001237NATRELLE Style 10-270 Gel Round Mod
10888628001244NATRELLE Style 10-300 Gel Round Mod
10888628001251NATRELLE Style 10-330 Gel Round Mod
10888628001268NATRELLE Style 10-360 Gel Round Mod
10888628001275NATRELLE Style 10-390 Gel Round Mod
10888628001282NATRELLE Style 10-420 Gel Round Mod
10888628001299NATRELLE Style 10-450 Gel Round Mod
10888628001312NATRELLE Style 10-510 Gel Round Mod
10888628001374NATRELLE Style 10-800 Gel Round Mod
10888628001381Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus
10888628001398NATRELLE Style 15-176 Gel Round Mod Plus
10888628001404NATRELLE Style 15-194 Gel Round Mod Plus
10888628001411NATRELLE Style 15-213 Gel Round Mod Plus
10888628001428NATRELLE Style 15-234 Gel Round Mod Plus
10888628001435NATRELLE Style 15-265 Gel Round Mod Plus
10888628001442NATRELLE Style 15-286 Gel Round Mod Plus
10888628001459NATRELLE Style 15-304 Gel Round Mod Plus
Lot codes and dates
  • MFG BATCHES

    3,621 of 3,621 codes

    • 2805096
    • 2836786
    • 2884422
    • 2889999
    • 2871740
    • 2878486
    • 2797264
    • 2884426
    • 3036126
    • 3059070
    • 3076451
    • 3124452
    • 3131479
    • 3139882
    • 3154328
    • 3157493
    • 3173220
    • 3176664
    • 3213097
    • 3228743
    • 2776706
    • 2884427
    • 2909055
    • 2921210
    • 3008017
    • 3022733
    • 3035530
    • 3059463
    • 3081093
    • 3096446
    • 3124773
    • 3127774
    • 3142976
    • 3154566
    • 3157086
    • 3157779
    • 3160817
    • 3164079
    • 3167339
    • 3173664
    • 3176918
    • 3182507
    • 3203867
    • 3208283
    • 3211090
    • 3226125
    • 2830860
    • 2868178
    • 2884428
    • 2917776
    • 2958518
    • 2961802
    • 3016093
    • 3019001
    • 3036261
    • 3059268
    • 3076606
    • 3091713
    • 3094037
    • 3124627

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 9, 2021 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.