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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/Home Healthcare

CADD-Solis Infusion Pumps Recalled for False Alarms and Infusion Interruptions

Agency Publication Date: May 7, 2025
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Summary

Smiths Medical ASD, Inc. is recalling 185,975 CADD-Solis HPCA and CADD-Solis VIP Ambulatory Infusion Pumps because they may trigger false 'Upstream Occlusion' alarms. These erroneous alarms stop the delivery of medication to the patient, which is dangerous if the patient depends on a continuous flow of therapy. The recall affects a wide range of model numbers and catalog codes used in hospitals and home care settings worldwide.

Risk

The infusion pump may incorrectly detect a blockage in the tubing and stop delivering medication. This interruption or delay in critical therapy can lead to serious patient injury or death, especially for patients requiring life-sustaining infusions.

What You Should Do

  1. This recall affects CADD-Solis HPCA and CADD-Solis VIP Ambulatory Infusion Pumps under multiple model and catalog numbers. Check the model number and Unique Device Identifier (UDI) on the device label; 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 authorized medical device distributor to arrange for a return, replacement, or correction of the affected equipment.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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 HPCA Ambulatory Infusion Pump
Variants: Clinical Evaluation/Demo Pump, English, French, Danish, Dutch, German, Italian, Japanese, Portuguese, Spanish, Swedish
Model / REF (54):
21-2111-0402-09-KYO
21-2111-0300-09_LOAN
21-2111-0300-09_CMSA
21-2111-0300-09_FUK
21-2111-0300-09_KYO
21-2111-0300-09_OKA
21-2111-0300-09_OMI
21-2111-0300-09_OSA
21-2111-0300-09_SAP
21-2111-0300-09_TOK
21-2111-0200-50JP
21-2111-0402-09-FUK
21-2111-0402-09-NAG
21-2111-0402-09-OKA
21-2111-0402-09-OSA
21-2111-0402-09-SAI
21-2111-0402-09-SAP
21-2111-0402-09-TOKE
21-2111-0402-09-TOKW
21-2112-0402-09-KYO
21-2112-0402-09-NAG
21-2112-0402-09-YOK
21-2111-0402-09-YOK
21-2111-0403-02
21-2111-0403-51
21-2111-0403-78
21-2112-0403-78
21-2112-0403-51
21-2112-0403-02
21-2111-0300-00
21-2111-0300-12
21-2111-0300-06
21-2111-0300-02
21-2111-0300-03
21-2111-0300-07
21-2111-0300-09JP
21-2111-0300-01
21-2111-0300-232
21-2111-0300-231
21-2111-0300-244
21-2111-0300-50
21-2111-0300-17
21-2111-0300-08
21-2111-0300-14
21-2112-0300-01
21-2112-0300-06
21-2112-0300-02
21-2112-0300-03
21-2112-0300-50
21-2112-0300-00
UDI (187):
10610586034787
10610586038778
10610586038785
10610586038808
10610586038822
10610586039232
10610586041037
10610586041051
10610586042591
10610586042669
10610586042829
10610586042836
15019517084368
15019517096378
15019517096385
15019517096392
15019517099690
15019517101003
15019517101010
15019517101034
15019517101041
15019517126587
15019517126594
15019517126600
15019517126617
15019517128697
15019517135343
15019517149999
15019517150001
15019517150292
15019517154290
15019517154887
15019517154924
15019517154979
15019517154986
15019517154993
15019517155006
15019517155013
15019517155044
15019517246735
15019517247008
15019517247169
15019517247176
15019517247183
15019517247206
00610586038900
00610586039310
04546027095620
04546027095637
04546027095644

Includes Clinical Evaluation and Demo pumps.

Product: CADD-Solis VIP Ambulatory Infusion Pump
Variants: Various software versions, International language versions
Model / REF (69):
21-2120-0100-02
21-2120-0100-03
21-2120-0100-06
21-2120-0100-232
21-2120-0100-233
21-2120-0100-50
21-2120-0100-51
21-2120-0100-95
21-2120-0102-02
21-2120-0102-03
21-2120-0102-06
21-2120-0102-07
21-2120-0102-08
21-2120-0102-12
21-2120-0102-13
21-2120-0102-14
21-2120-0102-15
21-2120-0102-17
21-2120-0102-237
21-2120-0102-238
21-2120-0102-247
21-2120-0102-249
21-2120-0102-51
21-2120-0102-78
21-2120-0102-92
21-2120-0102-97
21-2120-0102-98
21-2120-0103-01
21-2120-0103-02
21-2120-0103-03
21-2120-0103-06
21-2120-0103-07
21-2120-0103-08
21-2120-0103-12
21-2120-0103-14
21-2120-0103-15
21-2120-0103-17
21-2120-0103-249
21-2120-0103-51
21-2120-0103-78
21-2120-0104-01
21-2120-0104-231
21-2120-0105-00
21-2120-0105-01
21-2120-0105-02L
21-2120-0105-03L
21-2120-0105-06L
21-2120-0105-07L
21-2120-0105-08
21-2120-0105-08L
UDI (187):
10610586034787
10610586038778
10610586038785
10610586038808
10610586038822
10610586039232
10610586041037
10610586041051
10610586042591
10610586042669
10610586042829
10610586042836
15019517084368
15019517096378
15019517096385
15019517096392
15019517099690
15019517101003
15019517101010
15019517101034
15019517101041
15019517126587
15019517126594
15019517126600
15019517126617
15019517128697
15019517135343
15019517149999
15019517150001
15019517150292
15019517154290
15019517154887
15019517154924
15019517154979
15019517154986
15019517154993
15019517155006
15019517155013
15019517155044
15019517246735
15019517247008
15019517247169
15019517247176
15019517247183
15019517247206
00610586038900
00610586039310
04546027095620
04546027095637
04546027095644

Includes standard and loaner pumps in multiple software versions.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96620
Status: Active
Manufacturer: Smiths Medical ASD, Inc.
Sold By: Authorized medical device distributors; Hospitals; Home healthcare providers
Manufactured In: United States
Units Affected: 2 products (185,975 US; 127,701 OUS Total)
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.

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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.