SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Reported: January 28, 2026 Initiated: November 28, 2025 #Z-1121-2026
Product Description
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 585 units
- Distribution
- US Nationwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2. Recalled by Baxter Healthcare Corporation. Units affected: 585 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1121-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11