Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to 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 an FDA Class II medical device recall for a product contraindicated in a vulnerable population (infants/neonates). Although no illnesses or injuries have been reported, the product represents a risk-of-harm to this sensitive population group, meeting the criteria for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling the Cardinal Health GEL PACK REUSABLE, SMALL (Catalog Number 70204). The recall affects 409,738 units distributed nationwide and in Canada.
The product should not be used on infants or neonates. Cardinal Health is updating product labeling to include a caution statement reading "Not for use on Infants/Neonates."
Healthcare facilities, clinics, and individuals who have received this product should discontinue use on infants and neonates. Users are advised to review and follow the updated labeling instructions.
The recalled product
- Product
- Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 409,738
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 Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Similar recalls
- HighCardinal Health Umbilical Vessel Catheter recalled for sterility defect
FDA (Devices) · 2025-06-04
- HighCardinal Infant Heel Warmer recalled due to unapproved labeling changes
FDA (Devices) · 2022-01-26
- HighUmbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall
FDA (Devices) · 2025-06-04
- HighCardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
FDA (Devices) · 2013-04-03
- HighCardinal Health Umbilical Vessel Catheter Recall for Sterility Defect
FDA (Devices) · 2025-06-04
- HighCardinal Health Umbilical Vessel Catheter Insertion Tray Recall
FDA (Devices) · 2025-06-04