The Recall Desk
HighFDA (Devices)·Z-0185-2023·Announced 2022-11-16

Reusable gel pack recalled due to infant use contraindication

Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.

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 a risk-of-harm product where injury has not yet been reported, fitting the Score 3 (High) criterion. Although classified as FDA Class II, no illnesses or injuries have been reported, and the remedy is a labeling caution rather than a product replacement.

Plain-English summary

Cardinal Health 200, LLC is recalling approximately 1,915,308 units of Cardinal Health GEL PACK REUSABLE, EXTRA SMALL (Product Code 61115). According to the FDA notice, users should not use the product on infants or neonates. This is a Class II recall.

The recalled product was distributed nationwide and in Canada across all lots.

Cardinal Health is adding a caution statement to the product labeling that states: 'Not for use on Infants/Neonates.'

The recalled product

Product
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Thermal therapy device
Hazard
Affected units
1,915,308

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)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Cardinal Health 200, 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 8 products in this recall →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

See all →