Reported Dec 25, 2019 · Terminated

Natrelle Inspira Sillicone-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 Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes

71 of 71 products

Products covered by this recall
Model / numberProduct as published
10888628032835Natrelle 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)
10888628032842Natrelle Inspira SSM 175cc BI (US)
10888628032859Natrelle Inspira SSM 195cc BI (US)
10888628032866Natrelle Inspira SSM 210cc BI (US)
10888628032873Natrelle Inspira SSM 240cc BI (US)
10888628032880Natrelle Inspira SSM 255cc BI (US)
10888628032897Natrelle Inspira SSM 275cc BI (US)
10888628032903Natrelle Inspira SSM 295cc BI (US)
10888628032910Natrelle Inspira SSM 310cc BI (US)
10888628032927Natrelle Inspira SSM 330cc BI (US)
10888628032934Natrelle Inspira SSM 345cc BI (US)
10888628032941Natrelle Inspira SSM 360cc BI (US)
10888628032958Natrelle Inspira SSM 375cc BI (US)
10888628032965Natrelle Inspira SSM 405cc BI (US)
10888628032972Natrelle Inspira SSM 445cc BI (US)
10888628032989Natrelle Inspira SSM 485cc BI (US)
10888628032996Natrelle Inspira SSM 520cc BI (US)
10888628033009Natrelle Inspira SSM 560cc BI (US)
10888628033016Natrelle Inspira SSM 600cc BI (US)
10888628033023Natrelle Inspira SSM 640cc BI (US)
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new packaged foods recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 4:45 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.