Data Foundry

Medical device recalls 2023

KWIKSTIK — Class II medical device recall Z-0307-2024

Ongoing recall by Microbiologics Inc, reported 2023-11-22, distributed nationwide. A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus

Recall numberZ-0307-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2023-10-18
Classified2023-11-15
Reported by FDA2023-11-22
DistributedNationwide (US)
Countries outside the USFR, IT, MX, PE, TR
Quantity13 units
Pathogensmold
UPC / GTIN / UDI-DI20845357019169, 30845357019173
Lot numbers794-142-2, 794-142-3, 794-142-4

Product

KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

Reason for recall

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

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-0307-2024. 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.