Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
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: FDA Class I classification requires a minimum severity score of 4 per the rubric. Class I recalls indicate potential for serious injury or death. Although specific illnesses or injuries are not documented in the provided source, the Class I designation combined with worldwide distribution and large number of affected units indicates a critical safety issue.
Plain-English summary
Smiths Medical ASD Inc. is recalling the CADD-Solis VIP ambulatory infusion pump, including models 21-2120, 21-2125, and 21-2127, distributed worldwide. These pumps are indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, and subarachnoid space infusion. They are designed to deliver continuous infusion rates, intermittent bolus doses, and patient-controlled demand infusions.
The FDA has assigned this a Class I recall classification. Affected units are identified by multiple reference list numbers (21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-50, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-51, and 21-2120-0103-01) with corresponding Universal Device Identifiers and specific serial numbers.
Patients and healthcare providers using affected pumps should stop using them immediately and contact Smiths Medical ASD Inc. for instructions on device replacement or alternative infusion methods. To determine if a pump is affected, check the device's model number and serial number against the official FDA recall notice. Healthcare facilities should verify their inventory against the affected serial numbers.
The recalled product
- Product
- CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies…
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
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)
- REF List Number 21-2120-0100-02
- UDI/DI 10610586040429
- Serial Numbers: 1033919
- REF List Number 21-2120-0100-03
- UDI/DI 30610586040430
- Serial Numbers: 1024307
- 1024333
- 1025299
- 1027869
- 1027794
- REF List Number 21-2120-0100-50
- UDI/DI 10610586038501
- Serial Numbers: 1015104
- 1032637
- 1019622
- 1019666
- 1019677
- 1019718
- 1019720
- 1019790
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- HighSmiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding
FDA (Devices) · 2015-06-24
- LowSmiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message
FDA (Devices) · 2017-03-22
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14