Class 2 Device Recall Spectrum IQ

• Date Initiated by Firm: January 13, 2026
• Date Posted: February 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1368-2026
• Recall Event ID: 98306
• 510(K)Number: K251636
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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: Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 1-847-9484770
• Manufacturer Reason for Recall: Pumps were released without full testing being performed, including occlusion alarm testing.
• FDA Determined Cause: Employee error
• Action: 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.
• Quantity in Commerce: 5
• Distribution: States: Ohio Countries: United States
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN