CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Plum Solo Precision IV Pump recalled by ICU Medical

ICU Medical is recalling Plum Solo Precision IV Pump, 40001-0401, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3

Quantity recalled13,613

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-2311-2026
FDA event ID: 98872
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Infusion Pumps

Timeline

29 Apr 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+37 days
17 Jun 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

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Plum Solo Precision IV Pump, 40001-0401

Where it was distributed

Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

Nationwide Illinois Indiana Kansas Massachusetts Maryland New Mexico New York Pennsylvania Tennessee Texas

Questions about this recall

Is Plum Solo Precision IV Pump, 40001-0401 recalled?

Yes. ICU Medical recalled Plum Solo Precision IV Pump, 40001-0401 on 29 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2311-2026.

Why was it recalled?

Which lots are affected?

UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3

Where was it sold?

Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ICU Medical

All 654

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
27 May 2026Device	CLASS II	Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled	ICU Medical	Packaging Defects	Nationwide

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide