Baxter Healthcare Corporation Recalls
100 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (97)
- Class I
February 18, 2026
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
- Class II
February 18, 2026
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Visi
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
- Class II
January 13, 2026
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
Pumps were released without full testing being performed, including occlusion alarm testing.
- Class II
November 28, 2025
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
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.
- Class II
October 28, 2025
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
- Class II
September 17, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
- Class II
August 29, 2025
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Pr
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
IV sets may leak.
- Class II
August 29, 2025
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
IV sets may leak.
- Class II
August 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
IV sets may leak.
- Class II
August 8, 2025
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
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 I
August 4, 2025
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
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 result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
- Class I
August 4, 2025
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
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 result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
- Class I
August 4, 2025
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
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 result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
- Class II
July 14, 2025
Spectrum IQ Infusion Pump, Product Code 3570009
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 lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
- Class I
July 14, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
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 rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
- Class I
June 20, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Certain Spectrum infusion pumps may have an incorrect version of software.
- Class I
June 20, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Certain Spectrum infusion pumps may have an incorrect version of software.
- Class I
May 30, 2025
Hillrom 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;
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.
- Class I
May 30, 2025
Hillrom 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
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.
- Class II
May 12, 2025
Baxter 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.
- Class II
May 9, 2025
2.5 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.
- Class II
May 6, 2025
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E1
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 I
April 24, 2025
Baxter 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.
- Class I
April 7, 2025
Welch 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.
- Class I
April 7, 2025
Welch 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.
- Class II
March 24, 2025
Welch 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.
- Class II
March 24, 2025
Welch 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.
- Class II
March 24, 2025
Welch 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.
- Class II
March 21, 2025
Welch 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
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
March 21, 2025
Welch 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.
- Class II
March 21, 2025
Welch 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.
- Class II
March 21, 2025
Welch 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;
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
March 21, 2025
Welch 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
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
March 21, 2025
Welch 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) 75C
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
March 21, 2025
Welch 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
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Class II
March 3, 2025
Baxter 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.
- Class II
February 25, 2025
Progressa 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
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.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter Stationary column TruSystem 7500 U, Product Code 1730731
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter Floor mounting column TruSystem 7500, Product Code 1717021
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter Mobile column TruSystem 7500, Product Code 1717023
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter 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.
- Class II
February 25, 2025
Baxter 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.
- Class I
February 5, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Class I
February 5, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Class I
December 20, 2024
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
December 20, 2024
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
December 20, 2024
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class I
December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class I
December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class I
December 20, 2024
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
December 20, 2024
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
November 19, 2024
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Class II
November 19, 2024
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
October 16, 2024
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Drug Recalls (3)
- Class II
December 22, 2025
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Class II
August 20, 2025
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Discoloration
- Class II
October 30, 2024
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Hea
Labeling: Missing Label
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.