Smiths Medical ASD, Inc. medical device recall: CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96628
- 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
- 1
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
Pumps may experience Wireless Connection Modules intermittent connection alarms, 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. Distribution reported by FDA: Worldwide - US Nationwide distribution. Smiths Medical ASD, Inc. has 108 recalls in our records.
Recalled products (1)
Z-1662-2025 Class I Ongoing
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA…
Codes / lots: Affected CADD-Solis Software Versions: 4.0, 4.1, 4.2, 4.2.1, 4.3 UDI-DI: 4546027095675 4546027095682 10610586034787 10610586038778 10610586038785 10610586038808 10610586038822 10610586039232 10610586041037 10610586041051 15019517099690 15019517101003 15019517101010 15019517101034 15019517101041 15019517128697 15019517135343 15019517154290 15019517154887 15019517154924 15019517154979 15019517154986 15019517154993 15019517155006 15019517155013 15019517155044 15019517246735 15019517247008 15019517247169 15019517247176 15019517247183 15019517247206 00610586038900 00610586039310 04546027095620 04546027095637 04546027095644 04546027095668 04546027095699 04546027095705 04546027095712 04546027095729 04546027095736 04546027095897 04546027095903 04546027095910 04546027422983 04546027424116 04546027424130 04546027424147 04546027424178 04546027424185 04546027424192 04546027424208 04546027424598…
Quantity: US: 83,833 items ; OUS: 71,843 items
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 96628
- 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.