CLASS II ONGOING Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Onetouch Ultrasoft Lancets recalled by Cardinal Health
Cardinal Health is recalling Onetouch Ultrasoft Lancets, distributed nationwide in the US. The recall was initiated on 16 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1937-2021
- FDA event ID
- 87787
- Recalling firm
- Cardinal Health, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2021
- FDA classified
- 23 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 Mar 2021 | Recall initiated by company | |
| 23 Jun 2021 | Classified by FDA | +99 days |
| 30 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Where it was distributed
US Nationwide distribution in the states of FL, GA, SC.
Questions about this recall
Is Onetouch Ultrasoft Lancets recalled?
Yes. Cardinal Health recalled Onetouch Ultrasoft Lancets on 16 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-1937-2021.
Why was it recalled?
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.
Which lots are affected?
NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021
Where was it sold?
US Nationwide distribution in the states of FL, GA, SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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