Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to cus…
Reason for recall
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA 21-2111-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA ¿ 21-2112-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA ¿ 21-2111-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA 21-2112-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0402-51 PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA ¿ 21-2111-0100-51 PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA ¿21-2112-0100-51UDI-DI 4546027095675
What the firm is doing
Firm began notifying customers on April 10, 2025 via letters titled "Urgent Medical Device Correction." Customers were instructed to validate any wireless network changes or updates to hospital network settings with the pump/communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment. If the alarm recurs or is unable to be cleared by power cycling the pump, the customer should revert to prior compatible network settings or turn off the wireless function of the communication module. The firm will also address the issue with a software update. Smiths Medical will contact customers to schedule implementation of the software update once it is available.
DistributionShow detailsHide
Worldwide - US Nationwide distribution.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1662-2025
- FDA 510(k) clearance · K170982The device's official FDA premarket clearance record
- FDA device classification · MEAOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Smiths Medical ASD, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter.…
- Vascular Access Flush Saline
- Nonconforming Material/Component
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Intravascular Administration Set
- Under Investigation by firm
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
- Totally Implanted For Pain Relief Spinal-Cord Stimulator
- Device Design