Lower riskMedical device recall · FDA · Published July 16, 2024
Smiths Medical CADD-Solis Li-ion Battery Packs Recall: Risk of Melting Case
Smiths Medical recalls CADD-Solis Li-ion rechargeable battery packs (REF 21-2160-XX) sold in ambulatory infusion systems. Damage may cause short circuits, melting the battery case, and charging failure.
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
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Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer
Smiths Medical is recalling CADD-Solis Li-ion rechargeable battery packs (REF 21-2160-XX) that are part of certain ambulatory infusion systems. These batteries may have internal damage causing short circuits that could melt the battery case and disable the charging circuit. Read more at govinfonow.com/recall/54608-smiths-medical-cadd-solis-li-ion-battery-packs-recall-risk.
“Smiths Medical CADD-Solis Li-ion Battery Packs Recall: Risk of Melting Case.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54608-smiths-medical-cadd-solis-li-ion-battery-packs-recall-risk. Based on FDA recall #Z-0222-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2025%22&limit=1).
Smiths Medical ASD Inc. recalled CADD-Solis Li-ion Rechargeable Battery Packs on July 16, 2024, due to a short circuit hazard that could melt the case and render the charging circuit inoperable, according to the FDA.
Component of CADD Solis Ambulatory Infusion Systems with serial numbers including 21-2101-0100-50 through 22-4095-0205-25
The hazard
Damage to the battery pack may cause a short to a capacitor within the pack. This could lead to melting of the battery pack case even though the encasement is flame retardant. If this occurs, the charging circuit may become inoperable.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Recent similar recalls include Smiths Medical CADD Solis VIP Infusion Pump Recall (April 10, 2025), Smiths Medical CADD-Solis HPCA Infusion Pump Recall (April 10, 2025), and Smiths Medical CADD Solis HSPCA Pump Recall (April 10, 2025). Other recent recalls of similar products include Tobii Dynavox TD Navio Maxi Speech Device Recall (July 8, 2026) and HeartMate 11V Backup Battery Recall (May 13, 2026).
How to tell if you have this one
Check if your ambulatory infusion system includes any of the battery pack model numbers listed (REF 21-2160-XX) in the recall notice. All serial numbers are included in the list.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Battery Model
Identify if your battery pack has the model number REF 21-2160-XX as listed in the recall.
How this recall unfolded
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0222-2025 (July 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0222-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.