Brand Name: Spectrum IQ recallZ-1368-2026 · Baxter Healthcare Corporation · initiated Jan 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Pumps were released without full testing being performed, including occlusion alarm testing.
FDA root cause category: Employee error
What the company is doing
Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.
Recall details
- Recall number
- Z-1368-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 13, 2026
- Posted by the FDA
- Feb 13, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5
- Product code
- FRN
- FDA submissions
- K251636
- Distribution
- States: Ohio Countries: United States
Product description
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
Code information (models, lots, serial numbers)
Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
Other devices under the same FDA submission
1 device cleared under K251636 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Spectrum Wireless Battery 36010Baxter Healthcare Corporation · Accessories, pump, infusion2 deaths34 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page