Food, drugs, devices › Allergan PLC
Device recall: Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Sty
FDA enforcement event 83500 is a device recall by Allergan PLC of Irvine, CA, initiated 24 Jul 2019 and classified Class I, with 15 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Allergan PLC has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Allergan PLC, Irvine, CA.
Reason for recall
"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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2451-2019 | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2452-2019 | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125,… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2453-2019 | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250,… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2454-2019 | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203,… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2455-2019 | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16;… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2456-2019 | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12,… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2457-2019 | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE… | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2458-2019 | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2459-2019 | McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2460-2019 | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2461-2019 | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2462-2019 | Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2463-2019 | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2464-2019 | RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
| Z-2465-2019 | Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction | 4,026,287 Breast Implants and Tissue Expanders Combined in total | Class I | Ongoing | 18 Sep 2019 |
Context
Other enforcement events for Allergan PLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.