The Recall Desk
SevereFDA (Devices)·Z-0222-2025·Announced 2024-11-06

Ambulatory Infusion System Batteries May Short Circuit and Overheat

CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I recall requires a minimum severity of 4 per the rubric. While no illnesses or injuries have been reported, a potential short circuit and case melting in a battery pack powering an ambulatory infusion system—a critical medication delivery device—constitutes a serious hazard.

Plain-English summary

Smiths Medical ASD Inc. is recalling CADD-Solis Li-ion rechargeable battery packs (REF 21-2160-XX) and their associated ambulatory infusion systems. The recall affects 138,039 units worldwide, with all serial numbers included.

Battery pack damage may cause a short circuit to a capacitor within the pack. The battery case is designed to be flame retardant; however, this short circuit could lead to melting of the battery pack case. If the case melts, the battery pack charging circuit may become inoperable.

The recall includes both standalone battery packs and these packs as components of multiple CADD-Solis Ambulatory Infusion System models manufactured by Smiths Medical ASD Inc.

The recalled product

Product
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-210
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Ambulatory Infusion System
Hazard
  • short-circuit
  • battery-malfunction
  • overheating
  • fire-risk

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 serial numbers.

Distribution

Distribution scope not specified by the agency.

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