The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1681-2025·Announced 2025-05-14

CADD-Solis Infusion Pump Thermal Damage Risk Recall

Smiths Medical is recalling CADD-Solis infusion pumps worldwide due to a potential for thermal damage. The affected pumps include multiple models and variants distributed in the US and internationally.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a score of at least 4. Thermal damage in infusion pumps poses significant risk of patient harm or property damage, meeting the Severe classification criteria.

Plain-English summary

Smiths Medical ASD, Inc. is recalling CADD-Solis and CADD-Solis VIP infusion pumps due to a potential for thermal damage. The recall involves 313,676 total units across multiple models and variants, including pump kits with various configurations, software versions, and intended uses (commercial, trial/loaner, and demonstration units).

The affected infusion pumps were distributed worldwide with US nationwide distribution. All serial numbers of the affected models are included in this recall. Patients and healthcare facilities using these devices should immediately contact Smiths Medical for instructions on device replacement or repair.

Consumers or healthcare providers with questions about this recall, or who have experienced any issues with these devices, should contact Smiths Medical for guidance on next steps. The FDA classification for this recall is Class I.

The recalled product

Product
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL…
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
313,676

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 ) 21-2111-0402-51
  • UDI-DI: 15019517154290
  • 2 ) 21-2112-0402-51
  • UDI-DI: 15019517154993
  • 3 ) 21-2112-0100-51
  • UDI-DI: 10610586039232
  • 7 ) 21-2111-0100-51
  • UDI-DI: 30610586039205
  • 9 ) 21-2101-51
  • UDI-DI: 10610586031854
  • 13 ) 21-2111-0300-00
  • UDI-DI: 10610586038792
  • 14 ) 21-2111-0402-78
  • UDI-DI: 15019517154887
  • 15 ) 21-2111-0100-00
  • UDI-DI: 10610586039195
  • 16 ) 21-2112-0300-00
  • UDI-DI: 10610586038822
  • 17 ) 21-2112-0402-78
  • UDI-DI: 15019517155013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD, Inc.

See all →

Same hazard · thermal damage

See all →

Similar recalls