Data Foundry

Medical device recalls 2017

Urea Base Agar — Class III medical device recall Z-2221-2017

Terminated recall by Acumedia Manufacturers, Inc., reported 2017-06-14, distributed in AZ. Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿

Recall numberZ-2221-2017
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAcumedia Manufacturers, Inc., Lansing, MI, United States
Recall initiated2016-09-25
Classified2017-06-02
Reported by FDA2017-06-14
Terminated2017-06-02
DistributedAZ
Countries outside the USBR, CA, EC, GB
Quantity28 units
Reason classeslabeling
Lot numbers107, 108812APN, 699C, 7226A, 7226B

Product

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

Reason for recall

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

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-2221-2017. 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.