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.
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: 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
- 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
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