Data Foundry

Medical device recalls 2024

Keller Funnel 2 — Class II medical device recall Z-1694-2024

Ongoing recall by Allergan Sales, LLC, reported 2024-05-08, distributed nationwide. Their is a potential that breast implants lack the lubricious coating that allows them to slide through the fu

Recall numberZ-1694-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAllergan Sales, LLC, Irvine, CA, United States
Recall initiated2024-03-14
Classified2024-04-29
Reported by FDA2024-05-08
DistributedNationwide (US)
Quantity10,837
UPC / GTIN / UDI-DI10888628043725
Lot numbers23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Model numbersHA-001

Product

Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

Reason for recall

Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

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-1694-2024. 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.