Data Foundry

Medical device recalls 2022

KWIK-STIK — Class II medical device recall Z-0714-2022

Terminated recall by Microbiologics Inc, reported 2022-03-09, distributed nationwide. This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specifi

Recall numberZ-0714-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMicrobiologics Inc, Saint Cloud, MN, United States
Recall initiated2014-10-06
Classified2022-03-03
Reported by FDA2022-03-09
Terminated2023-01-17
DistributedNationwide (US)
Countries outside the USAE, AR, BE, BR, CA, CH, CL, CN, CO, DE, EC, FI, FR, GT, HK, HR, IE, IL, IN, IT, JP, KE, KR, LV, MY, NL, PA, PE, PL, PT, RO, SA, SG, TH, TR, TW, VN, ZA
Quantity150 units
Lot numbers959-74-1, 959-75-10, 959-75-2, 959-75-3, 959-75-6, 959-75-7, 959-76-2
Model numbersHL163263OEM

Product

KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299

Reason for recall

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

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-0714-2022. 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.