Natrelle recall
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC…
Why was Natrelle recalled?
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ALL LOTS Product Code/UDI Product Style 163: 163-360/10888628000704;163-440/10888628000711;163-530/10888628000728;163-655/10888628000735;163-780/10888628000742 Product Style 168: 168-120/10888628000759;168-150/10888628000766;168-180/10888628000773;168-210/10888628000780;168-240/10888628000797;168-270/10888628000803;168-300/10888628000810;168-330/10888628000827;168-360/10888628000834;168-390/10888628000841;168-420/10888628000858;168-450/10888628000865;168-480/10888628000872;168-510/10888628000889;168-550/10888628000896;168-600/10888628000902;168-650/10888628000919;168-700/10888628000926;168-750/10888628000933;168-800/10888628000940 Style 363: 363LF-170/10888628000957;363LF-200/10888628000964;363LF-230/10888628000971;363LF-260/10888628000988;363LF-300/10888628000995;363LF-330/10888628001008;363LF-370/10888628001015;363LF-410/10888628001022;363LF-450/10888628001039;363LF-510/10888628001046; 363LF-560/10888628001053;363LF-620/10888628001060;363LF-690/10888628001077; Style 468: 468-195/10888628001084;468-230/10888628001091;468-270/10888628001107;468-300/10888628001114;468-350/10888628001121;468-380/10888628001138;468-450/10888628001145;468-495/10888628001152;468-560/10888628001169;468-620/10888628001176
- Product
- Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC…
- Recalling firm
- Allergan PLC
- Quantity
- 4,026,287 Breast Implants and Tissue Expanders Combined in total
- Distribution
- Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.
- Recall date
- September 18, 2019
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)