The Recall Desk
HighFDA (Devices)·Z-1934-2021·Announced 2021-06-30

Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors

Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—temperature-exposed sensors may produce inaccurate glucose readings—but no actual incidents have been documented. This qualifies as high severity because it involves a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

Cardinal Health Inc. is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack (Item Number: 5447552). The affected devices were distributed nationwide in Florida, Georgia, and South Carolina. The recalled lot numbers were shipped between February 23, 2021 and March 10, 2021, and are identified by NDC/UPC: 8627005303.

The devices were exposed to temperature excursions of 31.9°F that occurred intermittently over a 2-hour and 15-minute period during shipping. This temperature exposure may cause the glucose sensors to produce inaccurate results.

Users of the affected Dexcom G6 Sensor 3-Pack kits should immediately stop using them and contact Cardinal Health for a replacement. Patients should consult with their healthcare provider regarding continuous glucose monitoring alternatives during this recall.

The recalled product

Product
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Manufacturer
Cardinal Health Inc.
Category
Medical Device — Continuous Glucose Monitor
Hazard
Affected units
2,357

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: 8627005303 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 · measurement error

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