FDA Device recall Z-0701-2020

Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 75…

FDA Device
Class III
terminated
Published 2019-12-25

On 2019-12-25 the FDA classified a Class III recall of Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 75… by Allergan, citing 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-….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0701-2020
Classification	Class III
Status	terminated
Initiated	2019-11-06
Published	2019-12-25
Last updated	2026-09-13 11:55 UTC
Company	Allergan
Distribution	AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY

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) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR

Reason

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.

Identifiers

code_info	MFG BATCHES: 2805096 2836786 2884422 2889999 2871740 2878486 2797264 2884426 3036126 3059070 3076451 312445… MFG BATCHES: 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 3127656 3142812 3148324 3160679 3167175 3189825 3192733 3195360 3210981 3222913 3225690 3228367 2776708 2836794 2884429 2889922 2946579 2954640 2969639 2984574 2996667 3022702 3033348 3036318 3048122 3054598 3059270 3072727 3086874 3094041 3111501 3122044 3124633 3127660 3148328 3157024 3160683 3182357 3185283 3187738 3192736 3194955 3195363 3201094 3210983 3213144 3218861 3220208 3222917 28573

code_info

MFG BATCHES: 2805096 2836786 2884422 2889999 2871740 2878486 2797264 2884426 3036126 3059070 3076451 312445…

MFG BATCHES: 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 3127656 3142812 3148324 3160679 3167175 3189825 3192733 3195360 3210981 3222913 3225690 3228367 2776708 2836794 2884429 2889922 2946579 2954640 2969639 2984574 2996667 3022702 3033348 3036318 3048122 3054598 3059270 3072727 3086874 3094041 3111501 3122044 3124633 3127660 3148328 3157024 3160683 3182357 3185283 3187738 3192736 3194955 3195363 3201094 3210983 3213144 3218861 3220208 3222917 28573

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0701-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.