CADD-Solis VIP Ambulatory Infusion Pump — Class I medical device recall Z-1668-2025

Ongoing recall by Smiths Medical ASD, Inc., reported 2025-05-14, distributed nationwide. Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will

Recall number	`Z-1668-2025`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Smiths Medical ASD, Inc., Minneapolis, MN, United States
Recall initiated	2025-04-10
Classified	2025-05-07
Reported by FDA	2025-05-14
Distributed	Nationwide (US)
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00610586038900`, `00610586039310`, `04546027095620`, `04546027095637`, `04546027095644`, `04546027095668`, `04546027095675`, `04546027095682`, `04546027095699`, `04546027095705`, `04546027095712`, `04546027095729`, `04546027095736`, `04546027095743`, `04546027095897`, `04546027095903`, `04546027095910`, `04546027422983`, `04546027424116`, `04546027424130`, `04546027424147`, `04546027424178`, `04546027424185`, `04546027424192`, `04546027424208` and 162 more
Model numbers	`21-2120-0100-02`, `21-2120-0100-03`, `21-2120-0100-06`, `21-2120-0100-232`, `21-2120-0100-233`, `21-2120-0100-50`, `21-2120-0100-51`, `21-2120-0100-95`, `21-2120-0102-02`, `21-2120-0102-03`, `21-2120-0102-06`, `21-2120-0102-07`, `21-2120-0102-08`, `21-2120-0102-12`, `21-2120-0102-13`, `21-2120-0102-14`, `21-2120-0102-15`, `21-2120-0102-17`, `21-2120-0102-237`, `21-2120-0102-238`, `21-2120-0102-247`, `21-2120-0102-249`, `21-2120-0102-51`, `21-2120-0102-78`, `21-2120-0102-92` and 44 more

Product

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

Reason for recall

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1668-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.