CLASS I ONGOING Device recall · Reported 18 Sep 2019 · FDA Enforcement Report
Natrelle 133 Tissue Expanders recalled by Allergan
Allergan is recalling Natrelle 133 Tissue Expanders (also named style 133 Biospan Tissue Expander and Mcghan, distributed nationwide in the US. The recall was initiated on 24 Jul 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2455-2019
- FDA event ID
- 83500
- Recalling firm
- Allergan, Irvine, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Jul 2019
- FDA classified
- 11 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Foreign Material
- Device type
- Infusion Pumps
Timeline
| 24 Jul 2019 | Recall initiated by company | |
| 11 Sep 2019 | Classified by FDA | +49 days |
| 18 Sep 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands. 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.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it 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.
Which lots are affected?
ALL LOTS Product Code/UDI STYLE 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972; STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153; STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092; STYLE 133FX: 133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030; STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214; STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-14 10888628003835, 133SX-15 10888628003842, 133SX-16 10888628003859; STYLE 133SV: 133SV-11 10888628003866, 133SV-12 10888628003873, 133SV-13 10888628003880, 133SV-14 10888628003897, 133SV-15 10888628003903, 133SV-16 10888628003910;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 83500This product is part of a recall event; the main page for the event is Natrelle, Saline-Filled Breast Implant Biocell Full Height recalled.
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