CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report

Spectrum IQ Infusion Pump recalled by Baxter Healthcare

Baxter Healthcare is recalling Spectrum IQ Infusion Pump, distributed in Ohio. The recall was initiated on 13 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

Quantity recalled5

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-1368-2026
FDA event ID: 98306
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jan 2026
FDA classified: 13 Feb 2026
Reported: 25 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

13 Jan 2026	Recall initiated by company
13 Feb 2026	Classified by FDA	+31 days
25 Feb 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

Pumps were released without full testing being performed, including occlusion alarm testing.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

Where it was distributed

States: Ohio Countries: United States

Ohio

Questions about this recall

Is Spectrum IQ Infusion Pump recalled?

Yes. Baxter Healthcare recalled Spectrum IQ Infusion Pump on 13 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1368-2026.

Why was it recalled?

Pumps were released without full testing being performed, including occlusion alarm testing.

Which lots are affected?

Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

Where was it sold?

States: Ohio Countries: United States

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 Baxter Healthcare

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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
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Other Infusion Pumps recalls

All 546

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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