Data Foundry

Medical device recalls 2024

KWIK-STIK Rhizopus stolonifer — Class II medical device recall Z-1483-2024

Ongoing recall by Microbiologics Inc, reported 2024-04-17, distributed nationwide. The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with anothe

Recall numberZ-1483-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2024-03-06
Classified2024-04-05
Reported by FDA2024-04-17
DistributedNationwide (US)
Countries outside the USFR, PE, ZA
Quantity19 units
Reason classesmicrobial contamination
Pathogensmold
UPC / GTIN / UDI-DI20845357003113, 30845357003127
Lot numbers209-37-1, 209-37-2, 209-37-3, 209-37-4, 209-37-5
Model numbers0209K, 0209P

Product

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

Reason for recall

The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

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-1483-2024. 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.