Manufacturer

Baxter Healthcare Corporation

279 recalls in our database name Baxter Healthcare Corporation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 279

SevereFDA (Devices)·Z-1637-2026·2026-04-08
Blue Ventilator Adapter Module Correction for Oxygen Desaturation Risk
Baxter Healthcare issued a Class I correction for the Blue Ventilator Adapter Module (Volara system accessory) due to potential oxygen desaturation and lung tissue injury risk in home care settings. Specific instructions for use are being provided.
Product
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1573-2026·2026-03-25
Welch Allyn VS100 Vision Screener display flickering may trigger seizures
The Welch Allyn Spot Vision Screener VS100 may display flickering due to a software issue. Flickering light exposure could trigger photosensitive seizures in susceptible individuals.
Product
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 Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit pe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2026·2026-02-25
Baxter Spectrum IQ Infusion Pump Recalled Over Incomplete Occlusion Alarm Testing
Baxter is recalling 5 Spectrum IQ infusion pumps distributed in Ohio due to incomplete testing, specifically missing occlusion alarm testing, which could affect medication delivery safety.
Product
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
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0296-2026·2026-02-04
Sterile Water for Irrigation Recalled Due to Plastic Particle Contamination
Baxter Healthcare Corporation is recalling 125,496 units of Sterile Water for Irrigation because plastic particles from the bottle rim have been observed floating into the solution. The nationwide recall affects lot number G171359.
Product
STERILE WATER — STERILE WATER (WATER)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2026·2026-01-28
SIGMA Spectrum Infusion Pump defective grease may cause over-infusion
Certain SIGMA Spectrum Infusion Pumps (Model 35700BAX2) contain defective grease on internal gears that may cause insufficient lubrication, leading to premature wear and potential over-infusion or free-flow. Baxter is recalling 585 units distributed nationwide.
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2026·2025-12-10
Welch Allyn Blood Pressure Cuff Replacement Bladders May Have Wrong Size
Baxter Healthcare is recalling Welch Allyn replacement bladders for two-piece blood pressure cuffs due to incorrect sizing. Some kits may contain a Large Adult bladder instead of the intended Thigh size, potentially resulting in inaccurate blood pressure readings.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0233-2026·2025-10-29
Oral Probes for Welch Allyn Thermometers Display Incorrectly Low Temperatures
Baxter is recalling oral thermometer probes that were programmed with the wrong configuration, causing them to show lower temperatures than actual. This could delay fever treatment.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0203-2026·2025-10-22
Medical Device IV Infusion Sets Recalled for Potential Leakage
Baxter Healthcare Corporation recalls CLEARLINK paclitaxel IV infusion sets that may leak during use. The 27,072 affected units were distributed nationwide; patients should contact their healthcare provider.
Product
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), Product Code 2R8858
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0202-2026·2025-10-22
Baxter IV infusion sets recalled nationwide for potential leaks
Baxter is recalling CLEARLINK CONTINU-FLO IV sets nationwide due to potential leaks. The voluntary recall affects 12,720 units distributed across all U.S. states.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2026·2025-10-22
Baxter ClearLink IV Solution Sets Recalled for Potential Leakage
Baxter Healthcare Corporation is recalling 18,720 ClearLink System Non-DEHP IV solution sets because they may leak. The nationwide voluntary recall was initiated on August 29, 2025.
Product
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2026·2025-10-22
Medical Device: CLEARLINK CONTINU-FLO Solution Sets Recalled for Potential Leaks
Baxter Healthcare is recalling CLEARLINK CONTINU-FLO IV solution sets (Product Code 2C8571, Lot R25B24055) due to potential leakage. Approximately 106,176 units were distributed nationwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2026·2025-10-22
IV Solution Sets Recalled Due to Potential Leakage Hazard
Baxter Healthcare is recalling 473,040 IV solution sets due to potential leakage. The affected product may malfunction during use, disrupting medication delivery.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2026·2025-10-22
IV Extension Sets Recalled for Potential Leakage
Baxter Healthcare is recalling CLEARLINK SYSTEM EXTENSION SETS nationwide due to potential leakage. The recall affects 2304 units with lot number R25C31031.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2026·2025-10-22
FDA Recalls Baxter IV Extension Sets Due to Potential Leakage
Baxter Healthcare recalls 16,416 CLEARLINK System Extension Sets due to potential leakage. The nationwide recall affects IV extension sets that may not function properly during use.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2026·2025-10-22
Baxter CLEARLINK IV Solution Sets Recalled for Potential Leaks
Baxter Healthcare has recalled over 1.1 million CLEARLINK SYSTEM CONTINU-FLO IV solution sets because they may leak. The recall affects nationwide distribution.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2026·2025-10-22
Baxter CLEARLINK IV Extension Sets Recalled for Leak Risk
Baxter Healthcare is recalling 15,552 IV extension sets that may leak during use. The voluntary recall affects units distributed nationwide; no injuries reported.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2026·2025-10-22
IV Solution Set Recalled Due to Potential Leaks
Baxter Healthcare is recalling 958,351 CLEARLINK SYSTEM CONTINU-FLO IV solution sets nationwide due to potential leaks. The voluntary recall affects units distributed to all 50 states.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2026·2025-10-22
IV Extension Sets Recalled for Potential Leakage
Baxter Healthcare is recalling CLEARLINK System Non_DEHP Extension Sets due to potential leakage in the IV sets. The voluntary recall affects products distributed nationwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2026·2025-10-22
FDA Recalls IV Administration Sets Over Potential Fluid Leakage
Baxter Healthcare Corporation is voluntarily recalling CLEARLINK System Solution Set IV administration sets that may leak. The recall affects 136,512 units distributed nationwide.
Product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0189-2026·2025-10-22
Baxter IV infusion sets recalled for potential leakage risk
Baxter Healthcare is recalling approximately 49,200 CONTINU-FLO Solution Sets nationwide due to potential leakage in IV infusion tubing. The voluntary recall affects two specific lot numbers.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2026·2025-10-22
Baxter Recalls IV Infusion Sets Nationwide for Potential Leaks
Baxter Healthcare Corporation is voluntarily recalling approximately 8,368 CLEARLINK SYSTEM CONTINU-FLO IV infusion sets nationwide due to the potential for leakage.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2026·2025-10-22
IV Administration Set Recalled Due to Potential Leakage Risk
Baxter Healthcare Corporation is recalling CLEARLINK SYSTEM Solution Sets (IV administration sets) because they may leak. The voluntary recall affects 1,440 units distributed nationwide.
Product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2026·2025-10-22
IV Solution Sets Recalled for Potential Leakage Risk Nationwide
Baxter Healthcare has recalled approximately 48,000 CLEARLINK SYSTEM CONTINU-FLO IV solution sets nationwide due to potential leakage. The voluntary recall affects lot R25C26116 distributed across all U.S. states.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2594-2025·2025-10-01
Baxter Continu-Flo Solution Sets recalled due to tubing separation risk
Baxter Healthcare recalls one lot of Continu-Flo intravascular administration sets nationwide due to customer reports of tubing separation. Affected users should stop using the product and contact Baxter or their healthcare provider.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2332-2025·2025-09-10
Infusion pump software anomalies may cause blank screens and false alerts
Baxter Healthcare recalls Novum IQ infusion pumps due to software anomalies that may cause blank display screens or false motor movement alerts. 43,922 units affected.
Product
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Category
Medical Device
Distribution
0 states