The Recall Desk
CriticalFDA (Devices)·Z-2457-2019·Announced 2019-09-18

Allergan Natrelle Tissue Expanders Recalled for Lymphoma Risk

Allergan is recalling Natrelle 133 tissue expanders due to FDA safety information regarding a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Allergan PLC is recalling Natrelle 133 Tissue Expanders with Suture Tabs, BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set. The recall covers specific styles including 133FV-T, 133MV-T, 133LV-T, 133SV-T, 133FX-T, 133MX-T, and 133SX-T, across all lots. The products are intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection.

The recall was initiated following notification by the U.S. Food and Drug Administration (FDA) regarding recently updated global safety information. This information indicates a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. The FDA has classified this recall as Class I.

The affected products were distributed worldwide and nationwide in the United States, including all fifty states, the District of Columbia, the US Virgin Islands, and Puerto Rico. International distribution included Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam. Patients who have these specific tissue expanders implanted should contact their healthcare provider for guidance regarding the safety information and potential removal.

The recalled product

Product
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-1
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implants and Tissue Expanders
Hazard
Affected units
4,026,287

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ALL LOTS
  • Product Code/UDI STYLE 133FV-T: 133FV-11-T 10888628004221
  • 133FV-12-T 10888628004238
  • 133FV-13-T 10888628004245
  • 133FV-14-T 10888628004252
  • 133FV-15-T 10888628004269
  • 133FV-16-T 10888628004276
  • STYLE 133MV-T: 133MV-11-T 10888628004405
  • 133MV-12-T 10888628004412
  • 133MV-13-T 10888628004429
  • 133MV-14-T 10888628004436
  • 133MV-15-T 10888628004443
  • 133MV-16-T 10888628004450
  • STYLE 133LV-T: 133LV-11-T 10888628004344
  • 133LV-12-T 10888628004351
  • 133LV-13-T 10888628004368
  • 133LV-14-T 10888628004375
  • 133LV-15-T 10888628004382
  • 133LV-16-T 10888628004399
  • STYLE 133FX-T: 133FX-11-T 10888628004283

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 15 recalled by Allergan PLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Related recalls

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Same hazard · anaplastic large cell lymphoma

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