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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

CADD-Solis Battery Packs Recalled for Overheating and Fire Risk

Agency Publication Date: October 31, 2024
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Summary

Smiths Medical ASD Inc. is recalling approximately 138,039 CADD-Solis Li-ion Rechargeable Battery Packs because they may overheat and melt. This issue is caused by a potential short circuit in a capacitor within the battery pack, which can also make the battery charging circuit stop working. The recall affects the battery packs both when sold individually and when included as a component of various CADD Solis Ambulatory Infusion Systems used to deliver medications to patients.

Risk

A short circuit in the battery can cause the plastic casing to melt, creating a fire hazard. If the battery pack fails, it may also prevent the infusion system from charging or operating, which could lead to an interruption in life-sustaining medical treatment.

What You Should Do

  1. The recalled products include CADD-Solis Li-ion Rechargeable Battery Packs (REF 21-2160-XX) and several models of CADD Solis Ambulatory Infusion Systems. All serial numbers are included in this recall. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Smiths Medical ASD Inc. or your medical equipment distributor to arrange for a return, replacement, or correction of the affected battery packs.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CADD-Solis Li-ion Rechargeable Battery Packs
Model / REF:
21-2160-XX
Serial Numbers:
All serial numbers

Sold individually and as a component of the infusion systems listed.

Product: CADD Solis Ambulatory Infusion Systems
Model / REF (183):
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
21-2101-0200-17
21-2101-0200-238
21-2101-249
21-2101-51
21-2102-0200-02
21-2102-249
21-2102-51
21-2111-0100-00
21-2111-0100-50
21-2111-0100-51
21-2111-0200-02
21-2111-0200-03
21-2111-0200-06
21-2111-0200-07
21-2111-0200-08
21-2111-0200-12
21-2111-0200-14
21-2111-0200-17
21-2111-0200-232
21-2111-0200-50
21-2111-0300-00
21-2111-0300-01
21-2111-0300-02
21-2111-0300-03
21-2111-0300-06
21-2111-0300-07
21-2111-0300-08
21-2111-0300-09
21-2111-0300-12
21-2111-0300-14
21-2111-0300-17
21-2111-0300-231
21-2111-0300-232
21-2111-0300-50
21-2111-0400-01
21-2111-0400-51
21-2111-0401-02L
21-2111-0401-03L
21-2111-0401-06L
21-2111-0401-07
21-2111-0401-07L
21-2111-0401-08L
21-2111-0401-12L

Recalled because they contain the affected CADD-Solis Li-ion Rechargeable Battery Packs.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95287
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Sold By: hospital supply chains; medical equipment distributors
Manufactured In: United States
Units Affected: 138039 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.