CADD Solis HSPCA Pump wireless connection alarm interruption recall
Smiths Medical is recalling CADD Solis HSPCA Pumps with wireless connection modules that may experience intermittent connection alarms, interrupting active infusions and risking serious patient injury or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall for a medical device where the hazard can lead to serious patient injury or death, meeting the Critical threshold. The source explicitly states risk of death as a consequence of therapy interruption.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD Solis HSPCA Pump kits due to a wireless connection issue. The pumps may experience intermittent connection alarms in the Wireless Connection Modules, which can interrupt an active infusion.
Interruption or delay of therapy can lead to serious patient injury or death. The recall affects software versions 4.0, 4.1, 4.2, 4.2.1, and 4.3 distributed worldwide, with approximately 83,833 items in the US and 71,843 items outside the US.
Customers using the wireless system should contact Smiths Medical or their healthcare provider for instructions on how to address this issue with their affected pump.
The recalled product
- Product
- 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Affected CADD-Solis Software Versions: 4.0
- 4.1
- 4.2
- 4.2.1
Distribution
Distributed nationwide across the United States.
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