Baxter Healthcare Corporation
Complete recall history across all FDA and CPSC categories — 404 total recalls
Recall Summary
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 |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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