RITZ PRINCESS — Class I medical device recall Z-2464-2019
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-2464-2019 |
|---|---|
| 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 |
Product
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
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-2464-2019. 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.