Baxter Healthcare

Reports per year

Source: FDA adverse event reports by year received, 2009–2025. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

• System, Peritoneal, Automatic DeliveryFKX8,402
• Set, Administration, For Peritoneal Dialysis, DisposableKDJ7,199
• Set, Administration, IntravascularFPA3,456
• Pump, InfusionFRN1,867
• Dialyzer, High Permeability With Or Without Sealed Dialysate SystemKDI194
• Pump, Infusion, ElastomericMEB136
• Refrigerator, Freezer, Blood StorageKSE132
• System, Irrigation, UrologicalLJH125
• System/Device, Pharmacy CompoundingNEP124
• Set, Blood TransfusionBRZ121

Recent recalls

• 2026-10-13Open, ClassifiedProcess control

  Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description: LIKORALL 242 ES, WHITE Product Code: 3122006NA Product Description: LIKORALL 242 ES, WHITE Product Code: 3122007 Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122007NA Product Description: LIKORALL 242 ES R2R, NATURAL Product Code: 3122008 Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122008NA Product Description: LIKORALL 242 ES R2R, WHITE Product Code: 3122009 Product Description: LIKORALL 242 S, NATURAL Product Code: 3122009NA Product Description: LIKORALL 242 S, NATURAL Product Code: 3122010 Product Description: LIKORALL 242 S, WHITE Product Code: 3122011 Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122011NA Product Description: LIKORALL 242 S R2R, NATURAL Product Code: 3122012 Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122012NA Product Description: LIKORALL 242 S R2R, WHITE Product Code: 3122501 Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122501NA Product Description: LIKORALL 250 ES, NATURAL Product Code: 3122502 Product Description: LIKORALL 250 ES, WHITE Product Code: 3122502NA Product Description: LIKORALL 250 ES, WHITE Product Code: 3123001 Product Description: LIKORALL 243 ES Product Code: 3123001NA Product Description: LIKORALL 243 ES Product Code: 3123002 Product Description: LIKORALL 243 ES, WHITE Product Code: 3123002NA Product Description: LIKORALL 243 ES, WHITE Product Code: 3124050 Product Description: LIKORALL 250 S, IRC

  Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

• 2026-09-24Open, ClassifiedProcess control

  PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

• 2026-09-24Open, ClassifiedProcess control

  PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

• 2026-09-24Open, ClassifiedProcess control

  PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14

  There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

• 2026-09-23Open, ClassifiedDevice Design

  Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No

  Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

• 2026-08-31Open, ClassifiedSoftware design

  Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

  A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

• 2026-08-31Open, ClassifiedSoftware design

  Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

  A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

• 2026-08-11Open, ClassifiedUnder Investigation by firm

  Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

  Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

• 2026-07-01Open, ClassifiedNonconforming Material/Component

  Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

  There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

• 2026-07-01Open, ClassifiedNonconforming Material/Component

  Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device

  There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.