The Recall Desk
SevereFDA (Devices)·Z-1682-2025·Announced 2025-05-14

CADD Solis VIP Ambulatory Infusion Pumps Recalled for Thermal Damage

Smiths Medical is recalling CADD Solis VIP infusion pumps due to a potential for thermal damage. All 313,676 units with any serial number distributed worldwide are included in this Class I recall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, which per the rubric requires a minimum severity score of 4 (Severe). While no illnesses or injuries are reported in the source, the FDA's Class I classification indicates a serious potential health risk requiring immediate action.

Plain-English summary

Smiths Medical ASD, Inc. is recalling CADD Solis VIP Ambulatory Infusion Pumps. The recall affects all 313,676 units, covering 15 different model variants with various configurations and languages.

The recall was issued due to a potential for thermal damage in the pumps. This thermal damage could affect device operation and patient safety.

The affected pumps were distributed worldwide, with US nationwide distribution included. All units with any serial number are within the scope of this recall.

The recalled product

Product
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 KI
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Infusion Pump
Hazard
  • thermal-damage
  • burn-injury

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 (20)

  • 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

Distribution

Distributed nationwide across the United States.

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