CLASS II ONGOING Device recall · Reported 30 Jun 2021 · FDA Enforcement Report

Onetouch Ultra Blue Test Strips recalled by Cardinal Health

Cardinal Health is recalling Onetouch Ultra Blue Test Strips, 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

Lot, batch or date codesNDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021

Quantity recalled5,356 boxes of 100 strips

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-1936-2021
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 ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

Where it was distributed

US Nationwide distribution in the states of FL, GA, SC.

Nationwide Florida Georgia South Carolina

Questions about this recall

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: 353885009713 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 87787

This product is part of a recall event; the main page for the event is Optichamber Diamond Spacer With Large Mask recalled by Cardinal Health.

Reported	Class	Recall	Company	Reason	Where
30 Jun 2021	CLASS II	Optichamber Diamond Spacer With Large Mask recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Accu-chek Smartview 100 Test Strips recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Freestyle Libre 2 Glucose Monitoring System recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Freestyle Libre 14 Day Glucose Monitoring System recalled	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Dexcom G6 Sensor recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Vaporizer Vicks recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Onetouch Delica Lancets recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Bd Uf Pen 32gx4mm 100 Nano recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Onetouch Ultra Test Strips recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Aerochamber Pls W/mask Lrg Blu recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Freestyle Lancets recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Onetouch Delica Lancets recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide
30 Jun 2021	CLASS II	Onetouch Ultrasoft Lancets recalled by Cardinal Health	Cardinal Health	Labeling Errors	Nationwide

More recalls from Cardinal Health

All 315

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium	Cardinal Health	Packaging Defects	KS
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
7 May 2025Drug	CLASS II	Wegovy (semaglutide) injection recalled by Cardinal Health	Cardinal Health	Temperature Abuse	NC, SC, VA

Other Insulin Pumps & Glucose Monitors recalls

All 459

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide