CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
Plum Solo Precision IV Pump, List Numbers: 400010401 (US) recalled
ICU Medical is recalling Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines), distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1120-2026
- FDA event ID
- 98128
- Recalling firm
- ICU Medical, Lake Forest, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2025
- FDA classified
- 16 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 15 Dec 2025 | Recall initiated by company | |
| 16 Jan 2026 | Classified by FDA | +32 days |
| 28 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Product as listed by the FDA
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Where it was distributed
Worldwide distribution - US Nationwide and the country of Philippines.
Questions about this recall
Why was it recalled?
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Which lots are affected?
400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
Where was it sold?
Worldwide distribution - US Nationwide and the country of Philippines.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98128This product is part of a recall event; the main page for the event is Plum Duo Infusion Pump, List Numbers: 400020401 (US) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Plum Duo Infusion Pump, List Numbers: 400020401 (US) recalled | ICU Medical | Other | Nationwide | |
| CLASS II | Plum Duo Precision IV Pump, List Numbers: 400020403 (US) recalled | ICU Medical | Other | Nationwide |
More recalls from ICU Medical
All 654| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hotline Fluid Warming Set, single use device recalled by ICU Medical | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Infusion Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Plum Duo Precision IV Pump recalled by ICU Medical | ICU Medical | Device Malfunction | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |