Baxter Healthcare Corporation

Complete recall history across all FDA and CPSC categories — 404 total recalls

Baxter Healthcare Corporation appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (36)

FDA drug safety enforcement actions by Baxter Healthcare Corporation

Date Product Reason Class
Dec 22, 2025 Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Ba... Presence of particulate matter: plastic particles from the bottle rim were ob... Class II
Aug 20, 2025 Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo ... Discoloration Class II
Oct 30, 2024 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... Labeling: Missing Label Class II
Aug 1, 2024 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... Microbial Contamination of Sterile Products; out of limit results obtained fo... Class I
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from ... Class II
Jan 23, 2024 Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... Incorrect product concentration on the overwrap label: The overwrap label inc... Class II
Nov 14, 2023 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... Failed pH Specifications Class II
Aug 24, 2023 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... CGMP Deviations: Product was exposed to temperatures exceeding the labeled st... Class II
Aug 14, 2023 Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial,... Labeling: Missing Label; customer complaint received that labels were partial... Class III
Aug 11, 2023 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, p... Lack of Assurance of Sterility: Potential presence of leaks originating from ... Class II
Aug 11, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FL... Lack of Assurance of Sterility: Potential presence of leaks originating from ... Class II
Mar 15, 2023 Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from ... Class II
Mar 15, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Amb... Lack of Assurance of Sterility: Potential presence of leaks originating from ... Class II
Aug 4, 2022 Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b... Temperature Abuse: Product distributed in refrigerated trucks with labels att... Class II
Oct 7, 2020 Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m... Presence of particulate matter in solution - black and transparent particles Class II
Nov 19, 2019 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare... Lack of Assurance of Sterility: Product has the potential to leak. Class II
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II
Jan 2, 2019 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Confirmed customer complaints for leaks on th... Class II
Oct 15, 2018 Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... Failed pH Specifications: Upward shift in the pH of the solution within the s... Class III
Sep 25, 2018 Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... Superpotent Drug: High out of specification results for levofloxacin resultin... Class III
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resultin... Class III
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ... Superpotent Drug: High out of specification results for levofloxacin resultin... Class III
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... Superpotent Drug: High out of specification results for levofloxacin resultin... Class III
Nov 10, 2017 Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... Presence of Particulate Matter:Particulate identified as polyethylene, the pr... Class I
Sep 15, 2017 Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... Temperature Abuse: A portion of this product lot was exposed to subfreezing t... Class I
Jul 6, 2017 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxt... Lack of Assurance of Sterility: Bags have the potential to leak. Class II
Jul 6, 2017 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxte... Lack of Assurance of Sterility: Bags have the potential to leak. Class II
Jul 6, 2017 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Ba... Lack of Assurance of Sterility: Customer complaints for leaking bags. Class II
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence... Class II
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence... Class II
Dec 6, 2016 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class II
Dec 6, 2016 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on... Discoloration: there were customer reports of yellow discolored solution. The... Class II
Sep 2, 2015 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Singl... Lack of Assurance of Sterility: Recalling firm reported a complaint for mold ... Class II

Device Recalls (368)

FDA medical device enforcement actions by Baxter Healthcare Corporation. Showing most recent 50.

Date Product Reason Class
Feb 18, 2026 Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... Display screen may unintentionally flicker due to a software issue. Exposure ... Class II
Jan 13, 2026 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3... Pumps were released without full testing being performed, including occlusion... Class II
Nov 28, 2025 SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Certain pumps have potentially been released from service with defective grea... Class II
Oct 28, 2025 Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product... Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure... Class II
Sep 17, 2025 Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp... Affected oral/axillary probes were inadvertently programmed with the rectal p... Class II
Aug 29, 2025 CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valve... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, thr... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standa... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... IV sets may leak. Class II
Aug 29, 2025 CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Ba... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing an... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, C... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... IV sets may leak. Class II
Aug 29, 2025 CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 d... IV sets may leak. Class II
Aug 8, 2025 Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for ... Class II
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction ... Class I
Aug 4, 2025 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction ... Class I
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction ... Class I
Jul 14, 2025 Spectrum IQ Infusion Pump, Product Code 3570009 Baxter has identified that certain pumps have potentially been released with ... Class II
Jul 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 ... Class I
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Certain Spectrum infusion pumps may have an incorrect version of software. Class I
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX 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 Mo... The Q-link 13 could allow for an improper attachment (false latching) of the ... Class I
May 30, 2025 Hillrom LikoScale component, Product Code 3156232, used with the following a... The Q-link 13 could allow for an improper attachment (false latching) of the ... Class I
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 p... Class II
May 9, 2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... The replacement rechargeable batteries inserted into the Welch Allyn PocketSc... Class II
May 6, 2025 Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... There is a potential for improper crimps on the signal wires of the actuators... Class II
Apr 24, 2025 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS There is a potential for the Novum IQ LVP due to the potential for underinfus... Class I
Apr 7, 2025 Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2... A cybersecurity vulnerability was discovered through internal testing. Class I
Apr 7, 2025 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-... A cybersecurity vulnerability was discovered through internal testing. Class I
Mar 24, 2025 Welch Allyn CP150 Electrocardiograph: There were customer reports of devices which experienced battery-related fire... Class II
Mar 24, 2025 Welch Allyn CONNEX Accessory Power Management Stand: There were customer reports of devices which experienced battery-related fire... Class II
Mar 24, 2025 Welch Allyn Connex Vital Signs Monitor (CVSM): There were customer reports of devices which experienced battery-related fire... Class II
Mar 21, 2025 Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 21, 2025 Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... Undeclared natural rubber band within the packaging of certain configurations... Class II
Mar 3, 2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for ... Class II
Feb 25, 2025 Baxter Mobile column TruSystem 7500, Product Code 1717023 There is a software issue which causes the upper back section to not be opera... Class II
Feb 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 opera... Class II

View all 368 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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