Baxter Healthcare Corporation
68 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Baxter Healthcare Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-07-23FDA-DeviceClass IBaxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Certain Spectrum infusion pumps may have an incorrect version of software.
- 2025-07-23FDA-DeviceClass IBaxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Certain Spectrum infusion pumps may have an incorrect version of software.
- 2025-07-16FDA-DeviceClass IHillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
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 patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- 2025-07-16FDA-DeviceClass IHillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .
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 patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- 2025-06-18FDA-DeviceClass IIBaxter Novum IQ Syringe Pump, product code 40800BAXUS,
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 stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
- 2025-06-18FDA-DeviceClass II2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
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 heat and user burns.
- 2025-06-04FDA-DeviceClass IIAffinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477
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.
- 2025-05-28FDA-DeviceClass IBaxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
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.
- 2025-05-21FDA-DeviceClass IWelch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
A cybersecurity vulnerability was discovered through internal testing.
- 2025-05-21FDA-DeviceClass IWelch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
A cybersecurity vulnerability was discovered through internal testing.
- 2025-04-23FDA-DeviceClass IIWelch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12)
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75MT-BR; 19) 75MX-B; 20) 75RE-B; 21) 75RT-B; 22) 75WE-B; 23) 75WT-B.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B; 18) 84MTVXX-2; 19) 84MXVEC-4; 20) 84MXVEC-B; 21) 84MXVEP-4; 22) 84MXVEP-B; 23) 84NTVE2-6; 24) 84NTVE2-B; 25) 84NTVE2-US; 26) 84NT
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceClass IIWelch Allyn CP150 Electrocardiograph:
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-23FDA-DeviceClass IIWelch Allyn CONNEX Accessory Power Management Stand:
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-23FDA-DeviceClass IIWelch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-02FDA-DeviceClass IIProgressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- 2025-04-02FDA-DeviceClass IIBaxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500, Product Code 4091000
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid (SC), Product Code 1854086
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid (FC), Product Code 1854085
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter TruSystem 7500 Hybrid (MC), Product Code 1773204
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-04-02FDA-DeviceClass IIBaxter Floor mounting column TS 7500 U, Product Code 1730732
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
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