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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 and CADD-Solis VIP Infusion Pumps Recalled for Overheating Risk

Agency Publication Date: May 5, 2025
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Summary

Smiths Medical ASD, Inc. is recalling 627,352 units of CADD-Solis and CADD-Solis VIP Infusion Pumps due to a defect that can cause the devices to overheat. This potential for thermal damage can lead to device failure, smoke, or fire, which could cause serious injury to patients. These pumps are used in hospitals and home healthcare settings to deliver critical medications.

Risk

The devices can suffer from internal thermal damage, causing them to overheat during operation. This poses a direct fire and burn risk and may result in the interruption of life-sustaining medication delivery.

What You Should Do

  1. This recall involves CADD-Solis Infusion Pumps (Model 2110/2100) and CADD-Solis VIP Ambulatory Infusion Pumps (Model 2120) which may overheat due to a potential for thermal damage.
  2. Identify if your device is affected by checking the model number and Unique Device Identifier (UDI) printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled infusion pumps immediately.
  4. Contact Smiths Medical ASD, Inc. or your authorized medical device distributor to arrange for the return, replacement, or correction of the affected equipment.
  5. Call the FDA at 1-888-463-6332 with any additional questions or concerns regarding this recall.

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 Infusion Pump Models
Variants: Model 2110, Model 2100, Yellow, CE English, NA English, V4.2, V4.1, V4.0, Trial/Loaner, Demo, HPCA PIB
Model / REF:
21-2111-0402-51
21-2112-0402-51
21-2112-0100-51
21-2112-0300-01
21-2111-0300-01
21-2111-0401-51
21-2111-0100-51
21-2112-0401-51
21-2101-51
21-2111-0400-51
21-2111-0300-50
21-2101-00
21-2111-0300-00
21-2111-0402-78
21-2111-0100-00
21-2112-0300-00
21-2112-0402-78
21-2101-249
21-2111-0401-78
21-2102-51
21-2112-0401-249
21-2111-0300-231
21-2112-0401-78
21-2112-0400-51
21-2112-0300-50
21-2111-0100-50
21-2112-0100-50
21-2112-0400-01
Serial Numbers:
All serial numbers
UDI:
15019517154290
15019517154993
10610586039232
30610586039205
10610586031854
10610586038792
15019517154887
10610586039195
10610586038822
15019517155013
10610586034787
10610586033933
10610586038785
15019517101034
10610586041051
10610586038860
10610586039256
10610586039270
35019517154904
10610586041822

Recall #: Z-1681-2025. Total affected quantity for this group: 313,676 units.

Product: CADD Solis VIP Ambulatory Infusion Pump Models
Variants: Model 2120, NA English, Manual Mode, PharmGuard Enabled, CE Global English, Trial/Loaner, NFHU, Factory Library
Model / REF:
21-2127-0105-01
21-2120-0105-01
21-2120-0103-01
21-2120-0102-51
21-2120-0104-01
21-2120-0103-51
21-2127-0104-01
21-2120-0105-00
21-2120-0103-78
21-2120-0102-78
21-2120-0104-231
21-2120-0102-249
21-2120-0103-249
21-2125-0104-01
Serial Numbers:
All serial numbers
UDI:
15019517150292
15019517150001
15019517084368
10610586042829
15019517126587
15019517096378
15019517126600
15019517149999
15019517096392
10610586042836
15019517126617
10610586042843
15019517096385
15019517126594

Recall #: Z-1682-2025. Total affected quantity for this group: 313,676 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96624
Status: Active
Manufacturer: Smiths Medical ASD, Inc.
Sold By: Hospitals; Healthcare facilities; Home health providers
Manufactured In: United States
Units Affected: 2 products (313,676 total units; 313,676 items)
Distributed To: Nationwide
Agency Last Updated: May 16, 2025

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.

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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.