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KWIK-STIK™ 0621URecalls & reported problems

Microbiologics Inc. · KWIK-STIK™ O. urethralis ATCC 17960™ · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 27, 2025Open, Classified

    Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

    Z-1957-2025 · Root cause: Mixed-up of materials/components · FDA record ↗

Other KIT, QUALITY CONTROL FOR CULTURE MEDIA devices

All KIT, QUALITY CONTROL FOR CULTURE MEDIA devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.