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Use caution Medical device recall · FDA · Published April 10, 2025

Smiths Medical CADD Solis HSPCA Pump: Wireless Connection Alarms Risk Serious Injury

Smiths Medical recalls CADD Solis HSPCA Pumps with wireless systems that may interrupt therapy, risking serious injury or death. Affected models include specific software versions and pump kits.

🇺🇸 FDA recall #Z-1662-2025Medical deviceSmiths Medical ›
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Recalling firmSmiths Medical ASD, Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer

What happened, in plain English

Smiths Medical is recalling CADD Solis HSPCA Pumps that use wireless systems. These pumps may show intermittent connection alarms, which can interrupt therapy and lead to serious injury or death if not addressed. Read more at govinfonow.com/recall/52472-smiths-medical-cadd-solis-hspca-pump-wireless-connection-alarms-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52472-smiths-medical-cadd-solis-hspca-pump-wireless-connection-alarms-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1662-2025

Cite this page

“Smiths Medical CADD Solis HSPCA Pump: Wireless Connection Alarms Risk Serious Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52472-smiths-medical-cadd-solis-hspca-pump-wireless-connection-alarms-risk. Based on FDA recall #Z-1662-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1662-2025%22&limit=1).

Why it’s dangerous

The wireless connection modules in these pumps may trigger intermittent alarms that interrupt active therapy. This interruption or delay in treatment can cause serious injury or death in patients who rely on the pump for life support.

Who’s affected

Patients using wireless CADD Solis HSPCA Pumps with specific software versions (4.0 to 4.3) and pump kits are affected. Those with the pumps in the list of affected models are most at risk.

How to tell if you have this one

Check if your pump kit includes the model numbers listed: CADD SOLIS HPCA, MDL 2110, or CADD-SOLIS, with software versions 4.0 to 4.3. Also, look for the specific pump kit codes mentioned in the recall notice.

  • Brand
    Smiths Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Model

    Identify your pump kit model and software version to confirm if it's affected by the recall.

  2. Contact Manufacturer

    Reach out to Smiths Medical for guidance on next steps if your pump is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Apr 10, 202512. FDA classified it Class I: May 7, 202523. Published in FDA’s Enforcement Report: May 14, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1662-2025 (April 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1662-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA