Data Foundry

Medical device recalls 2021

ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 — Class II medical device recall Z-1939-2021

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-1939-2021
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-DI00812608030026
Model numbers5541610

Product

ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

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-1939-2021. 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.