Cardinal Health Insulated Gel Pack recalled; not safe for infants
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
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 no injuries have been reported, meeting the rubric criterion for Score 3 (High). The FDA Class II designation and absence of reported illness prevent a higher score.
Plain-English summary
Cardinal Health 200, LLC is recalling the INSULATED GEL PACK REUSABLE, LARGE (Cat. 80104) distributed nationwide and in Canada. Approximately 1,209,260 units are affected across all lot codes.
The product is not safe for use on infants or neonates. The company will add a warning label that reads: 'Not for use on Infants/Neonates.'
If you have this product, do not use it on infants or neonates. Healthcare facilities and retailers should ensure the warning label is in place.
The recalled product
- Product
- Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device
- Hazard
- Affected units
- 1,209,260
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 →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · burn injury
See all →- SevereDREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn Hazards
CPSC · 2026-10-29
- HighQZH.DUAO Children's Pajama Sets Recalled for Burn Hazard
CPSC · 2026-10-29
- SevereHAIARA Power Banks Recalled Due to Fire and Burn Hazards
CPSC · 2026-10-29
- SevereWhatever Works Recalls Microwave Grills Due to Fire Hazard
CPSC · 2026-10-29
- Severe
Similar recalls
- HighCardinal Health Umbilical Vessel Catheter recalled for sterility defect
FDA (Devices) · 2025-06-04
- HighCardinal Health Umbilical Vessel Catheter Insertion Tray Recall
FDA (Devices) · 2025-06-04
- HighCardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health Recalls Enteral Infusion Pumps Due to Air Risk
FDA (Devices) · 2021-04-14
- HighCardinal Health Surgical Gowns Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-12-22
- HighCardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals
FDA (Devices) · 2021-12-22