Agency classClass IIOur severity:High FDA (Devices)·Z-2444-2015·Announced 2015-09-02

FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II. The hazard involves potential skin and eye irritation from chemical spillage, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as a widespread outcome.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 164,749 units of Covidien Argyle Infant Heel Warmers (with tab), Item Code MH00002T. The recall is due to a defect where the warmers may break during activation, resulting in the spillage of contents onto patients or healthcare workers. This spillage can cause potential skin or eye irritations.

The affected products were distributed worldwide, including in the United States, Canada, Mexico, Panama, and Japan. The recall covers specific lot codes, including 309907X, 310604X, 310704X, 312110X, 312329X, 313034X, 313615X, 314212X, 314308X, 317921X, 318904X, 320714X, 320715X, 321312X, 321423X, 321712X, 321812X, 321826X, 321903X, and 322120X.

Healthcare facilities and consumers should stop using these products immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Manufacturer: Covidien LLC
Category: Medical Device — Infant Care
Hazard: chemical-irritation
skin-irritation
eye-irritation

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Covidien LLC 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 2 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · chemical irritation