Smiths Medical ASD, Inc. medical device recall: CADD-Solis HPCA Ambulatory Infusion Pump
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96620
- Recall initiated
- Apr 10, 2025
- Classified by FDA
- May 7, 2025
- Posted in Enforcement Report
- May 14, 2025
- Recalling firm
- Smiths Medical ASD, Inc.
- Firm location
- Minneapolis, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 10, 2025. FDA classified it 27 days later, on May 7, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide - US nationwide distribution. Smiths Medical ASD, Inc. has 108 recalls in our records.
Recalled products (2)
Z-1667-2025 Class I Ongoing
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS…
Codes / lots: All CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps UDI-DI: 10610586034787 10610586038778 10610586038785 10610586038808 10610586038822 10610586039232 10610586041037 10610586041051 10610586042591 10610586042669 10610586042829 10610586042836 15019517084368 15019517096378 15019517096385 15019517096392 15019517099690 15019517101003 15019517101010 15019517101034 15019517101041 15019517126587 15019517126594 15019517126600 15019517126617 15019517128697 15019517135343 15019517149999 15019517150001 15019517150292 15019517154290 15019517154887 15019517154924 15019517154979 15019517154986 15019517154993 15019517155006 15019517155013 15019517155044 15019517246735 15019517247008 15019517247169 15019517247176 15019517247183 15019517247206 00610586038900 00610586039310 04546027095620 04546027095637 04546027095644 04546027095668 04546027095675 04546027095682 04546027095699 04546027095705…
Quantity: 185,975 US; 127,701 OUS Total
Z-1668-2025 Class I Ongoing
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
Codes / lots: All CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps UDI-DI: 10610586034787 10610586038778 10610586038785 10610586038808 10610586038822 10610586039232 10610586041037 10610586041051 10610586042591 10610586042669 10610586042829 10610586042836 15019517084368 15019517096378 15019517096385 15019517096392 15019517099690 15019517101003 15019517101010 15019517101034 15019517101041 15019517126587 15019517126594 15019517126600 15019517126617 15019517128697 15019517135343 15019517149999 15019517150001 15019517150292 15019517154290 15019517154887 15019517154924 15019517154979 15019517154986 15019517154993 15019517155006 15019517155013 15019517155044 15019517246735 15019517247008 15019517247169 15019517247176 15019517247183 15019517247206 00610586038900 00610586039310 04546027095620 04546027095637 04546027095644 04546027095668 04546027095675 04546027095682 04546027095699 04546027095705…
Quantity: 185,975 US; 127,701 OUS Total
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96620
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.