CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.
FDA device recall Z-1662-2025 · posted 2025-05-07 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Action taken
- 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. ***Updated 5/28/2026*** On 5/27/26, firm revised the scope of the action to apply specifically to CADD customers using the wireless system. All current wireless customers, as well as any customers who upgrade to wireless, will receive the updated CADD firmware connection. All future implementations - both wireless and non-wireless - will include the corrected CADD firmware.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MEA
- Quantity affected
- US: 83,833 items ; OUS: 71,843 items
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2025-04-10
- Date posted
- 2025-05-07
- Location
- Minneapolis, MN
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