Medical DeviceOct 22, 2025
Baxter Healthcare CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves recall — FDA Z-0189-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Recall history in this database
Classification mix: Class II: 260, Class I: 60, Class III: 8.
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard recall — FDA Z-0197-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set recall — FDA Z-0200-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer recall — FDA Z-0192-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter recall — FDA Z-0196-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer recall — FDA Z-0201-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard recall — FDA Z-0199-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated recall — FDA Z-0191-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 1, 2025
Baxter Healthcare Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated recall — FDA Z-2594-2025
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 10, 2025
Baxter Healthcare Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall — FDA Z-2333-2025
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 10, 2025
Baxter Healthcare Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall — FDA Z-2332-2025
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 10, 2025
Baxter Healthcare Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump recall — FDA Z-2334-2025
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 3, 2025
Baxter Healthcare Spectrum IQ Infusion Pump, Product Code 3570009 recall — FDA Z-2415-2025
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceAug 20, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS recall — FDA Z-2173-2025
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX recall — FDA Z-2095-2025
Certain Spectrum infusion pumps may have an incorrect version of software.
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 23, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 recall — FDA Z-2096-2025
Certain Spectrum infusion pumps may have an incorrect version of software.
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 16, 2025
Baxter Healthcare Hillrom LikoScale component, Product Code 3156232, used with the following recall — FDA Z-2032-2025
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 16, 2025
Baxter Healthcare Hillrom Q-Link 13 component, Product Code 3156509, used with the following recall — FDA Z-2031-2025
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 18, 2025
Baxter Healthcare 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN recall — FDA Z-1962-2025
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 18, 2025
Baxter Novum IQ Syringe Pump, product code 40800BAXUS recall — FDA Z-1964-2025
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 4, 2025
Baxter Healthcare Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432 recall — FDA Z-1816-2025
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceMay 28, 2025
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS recall — FDA Z-1767-2025
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 23, 2025
Baxter Healthcare Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) recall — FDA Z-1564-2025
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 23, 2025
Baxter Healthcare Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers recall — FDA Z-1563-2025
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class IIFDA: OngoingBaxter Healthcare Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Baxter Healthcare Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.