ICU Medical, Inc. medical device recall: Plum Duo Infusion System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97186
- Recall initiated
- Jul 11, 2025
- Classified by FDA
- Aug 6, 2025
- Posted in Enforcement Report
- Aug 13, 2025
- Recalling firm
- ICU Medical, Inc.
- Firm location
- Lake Forest, IL, 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
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
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 Jul 11, 2025. FDA classified it 26 days later, on Aug 6, 2025. Distribution reported by FDA: US Nationwide. ICU Medical, Inc. has 75 recalls in our records.
Recalled products (1)
Z-2129-2025 Class I Ongoing
Plum Duo Infusion System, List Number: 400020401
Codes / lots: UDI-DI: M335400021; Serial Numbers: 50000124 50004386 50006225 50000300 50003767 50006228 50004719 50005562 50001512 50002063 50002087 50000125 50004387 50006224 50001628 50003768 50006227 50004720 50005566 50001513 50002064 50002091 50000126 50004389 50006223 50001785 50003775 50006218 50004722 50005572 50001514 50002065 50002107 50000127 50004390 50006220 50002461 50003776 50006205 50004725 50005619 50001515 50002066 50002114 50000128 50004391 50006217 50002491 50003785 50006198 50004726 50005639 50001516 50002067 50002120 50000129 50004392 50006215 50002541 50003786 50006197 50004727 50005663 50001517 50002068 50002123 50000130 50004393 50006214 50002598 50003787 50006183 50004729 50005669 50001518 50002069 50002126 50000131 50004394 50006213 50002599 50003789 50006163 50004730 50005678 50001519 50002070 50002128 50000132 50004395 50006212 50002603 50003793 50006151 50004731 50005680…
Quantity: 4677 units
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 97186
- 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.