smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-...

FDA Device Recall #Z-0466-2025 — Class II — June 26, 2024

Recall Summary

Recall Number Z-0466-2025
Classification Class II — Moderate risk
Date Initiated June 26, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smiths Medical ASD, Inc.
Location Minneapolis, MN
Product Type Devices
Quantity 156,400 AC adapters

Product Description

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

Reason for Recall

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

Distribution Pattern

Worldwide distribution.

Lot / Code Information

Model 21-0270-25, UDI/DI 15019517126844, All lots

Other Recalls from Smiths Medical ASD, Inc.

Recall # Classification Product Date
Z-1667-2025 Class I CADD-Solis HPCA Ambulatory Infusion Pump; Mode... Apr 10, 2025
Z-1681-2025 Class I CADD-Solis Infusion Pump Models: 1) PUMP KIT,... Apr 10, 2025
Z-1668-2025 Class I CADD-Solis VIP Ambulatory Infusion Pump; Mode... Apr 10, 2025
Z-1662-2025 Class I CADD Solis HSPCA Pump Apr 10, 2025
Z-1682-2025 Class I CADD Solis VIP Ambulatory Infusion Pump Models:... Apr 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.