Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231; 12) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249; 13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-249; 14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01; 15) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.
Why it was recalled
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
All serial numbers. 1 ) 21-2127-0105-01 , UDI-DI: 15019517150292 ; 2 ) 21-2120-0105-01 , UDI-DI: 15019517150001 ; 3 ) 21-2120-0103-01 , UDI-DI: 15019517084368 ; 4 ) 21-2120-0102-51 , UDI-DI: 10610586042829 ; 5 ) 21-2120-0104-01 , UDI-DI: 15019517126587 ; 6 ) 21-2120-0103-51 , UDI-DI: 15019517096378 ; 7 ) 21-2127-0104-01 , UDI-DI: 15019517126600 ; 8 ) 21-2120-0105-00 , UDI-DI: 15019517149999 ; 9 ) 21-2120-0103-78 , UDI-DI: 15019517096392 ; 10 ) 21-2120-0102-78 , UDI-DI: 10610586042836 ; 11 ) 21-2120-0104-231 , UDI-DI: 15019517126617 ; 12 ) 21-2120-0102-249 , UDI-DI: 10610586042843 ; 13 ) 21-2120-0103-249 , UDI-DI: 15019517096385 ; 14 ) 21-2125-0104-01 , UDI-DI: 15019517126594 ; 15 ) 21-2120-0102-249 , UDI-DI: 10610586042843 ;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution.
Recall record
- Recalling firm
- Smiths Medical ASD, Inc.
- Product type
- Devices
- Recall number
- Z-1682-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Minneapolis, MN
- Recall initiated
- 2025-04-10
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1682-2025 · Source: openFDA enforcement.