Natrelle 133 Tissue Expanders — Class I medical device recall Z-2455-2019
Ongoing recall by Allergan PLC, reported 2019-09-18, distributed nationwide. The action was initiated following notification by the U.S. FDA of their recently updated, global safety infor
| Recall number | Z-2455-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan PLC, Irvine, CA, United States |
| Recall initiated | 2019-07-24 |
| Classified | 2019-09-11 |
| Reported by FDA | 2019-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA, CL, JP, KR, TH, TW, VN |
| Quantity | 4,026,287 breast |
| UPC / GTIN / UDI-DI | 10888628003804, 10888628003811, 10888628003828, 10888628003835, 10888628003842, 10888628003859, 10888628003866, 10888628003873, 10888628003880, 10888628003897, 10888628003903, 10888628003910, 10888628003927, 10888628003934, 10888628003941, 10888628003958, 10888628003965, 10888628003972, 10888628003989, 10888628003996, 10888628004009, 10888628004016, 10888628004023, 10888628004030, 10888628004047 and 17 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2455-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.