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
Device Recalls (368)
FDA medical device enforcement actions by Baxter Healthcare Corporation. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 18, 2026 | PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identificat... | Class II |
| Aug 18, 2026 | PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technolog... | There is an error in the product description on the Unique Device Identificat... | Class II |
| Aug 18, 2026 | PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identificat... | Class II |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infu... | Class II |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infu... | Class II |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected... | Class II |
| Jun 30, 2026 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... | Baxter received customer reports of air bubbles in the drip chamber and tubin... | Class I |
| May 21, 2026 | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... | There have been reports of air and medication leakage from the nebulizer cup ... | Class I |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... | There have been reports of air and medication leakage from the nebulizer cup ... | Class I |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... | There have been reports of air and medication leakage from the nebulizer cup ... | Class I |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... | There have been reports of air and medication leakage from the nebulizer cup ... | Class I |
| Apr 22, 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron f... | Class II |
| Apr 21, 2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... | The Adapter for Head Positioning accessory may become loose during patient po... | Class II |
| Feb 18, 2026 | Blue Ventilator Adapter Module, single-patient use circuit, Product Code M079... | Urgent Medical Device Correction for the Volara system single-patient use cir... | Class I |
| 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 |
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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