The Recall Desk
HighFDA (Devices)·Z-1939-2021·Announced 2021-06-30

OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping

Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of blood glucose testing lancets with potential for inaccurate results from temperature exposure. No injuries or illnesses reported, and the hazard is theoretical, so per rubric criteria this qualifies as High (3) severity.

Plain-English summary

CardinalHealth, Inc. is recalling 2,315 boxes of OneTouch Delica Lancets, 30G, 100-count because they were exposed to freezing temperatures during shipping. During transit, the devices experienced temperature drops to 31.9°F over intermittent 2-hour periods, which may cause inaccurate blood glucose test results.

The affected product (NDC/UPC: 812608030026) was distributed in Florida, Georgia, and South Carolina. All lot numbers shipped from February 23 through March 10, 2021 are included in the recall.

If you have used these lancets, monitor your blood glucose readings closely and verify device integrity. Contact your healthcare provider or manufacturer if you have concerns about whether your devices are affected.

The recalled product

Product
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Lancets / Glucose Testing
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • NDC/UPC: 812608030026 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cardinal Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature degradation

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