Data Foundry

Medical device recalls 2021

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 — Class II medical device recall Z-1936-2021

Ongoing recall by Cardinal Health Inc., reported 2021-06-30, distributed nationwide. Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 h

Recall numberZ-1936-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCardinal Health Inc., Dublin, OH, United States
Recall initiated2021-03-16
Classified2021-06-23
Reported by FDA2021-06-30
DistributedNationwide (US)
Reason classestemperature control
UPC / GTIN / UDI-DI00353885009713
Model numbers2990174

Product

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

Reason for recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

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-1936-2021. 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.