Data Foundry

Medical device recalls 2020

LemonPrep Tubes — Class II medical device recall Z-1548-2020

Terminated recall by Carroll-Baccari, Inc., reported 2020-04-01, distributed nationwide. Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15

Recall numberZ-1548-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCarroll-Baccari, Inc., Riviera Beach, FL, United States
Recall initiated2019-12-23
Classified2020-03-20
Reported by FDA2020-04-01
Terminated2021-09-28
DistributedNationwide (US)
Countries outside the USAU, CA, ES, GB
Quantity8,030 units
Pathogensburkholderia

Product

LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)

Reason for recall

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

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-1548-2020. 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.