Recall Z-1121-2026 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
| Date | Jan 16, 2026 (initiated Nov 28, 2025) |
| Status | Open, Classified |
| Reason | Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/28/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the impacted product (see Attachment A for complete list of affected serial numbers). The product code and serial number can be found on the bottom of the infusion pump. 2. If you received this communication directly from Baxter, please acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will preven |
| Quantity | 585 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation, Jul 28, 2025 |