FDA Devices recall · Reported November 16, 2022
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Cardinal Health 200, LLC recalled Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 - a moderate-severity action.
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 was recalled by Cardinal Health 200, LLC in November 16, 2022. Reason: Users are being informed that the product should not be used on infants/neonates. A caution statement will be…. Check the official notice for the remedy. Verify recall #Z-0185-2023 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-Users are being informed that the product should not be used on infants/neonates. A caution statement will be….
- Moderate
- severity level
- 1.9M units
- affected scope
- Class II
- classification
- November 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0185-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) places it in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices and 2 from Cardinal Health 200, LLC - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Reason for recall
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0185-2023 |
| Date reported | November 16, 2022 |
| Date initiated | September 28, 2022 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Waukegan, IL |
| Affected scope | 1915308 units |
| Distribution | nationwide and Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0185-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026