DrugSep 9, 2026
DAPTOMYCIN IN SODIUM CHLORIDE Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per recall — FDA D-0821-2026
CGMP Deviations
Class IIFDA: OngoingBaxter Healthcare Corporation
Recall history in this database
Classification mix: Class II: 260, Class I: 60, Class III: 8.
DrugSep 9, 2026
DAPTOMYCIN IN SODIUM CHLORIDE Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 recall — FDA D-0807-2026
CGMP Deviations
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 9, 2026
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS recall — FDA Z-3065-2026
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.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 9, 2026
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA Z-3066-2026
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.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceAug 19, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507 recall — FDA Z-2766-2026
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.
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 8, 2026
Baxter Healthcare Hillrom VOLARA System P.CIRCUIT KIT AC recall — FDA Z-2550-2026
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…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 8, 2026
Baxter Healthcare Adapter for Head Positioning recall — FDA Z-2638-2026
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 8, 2026
Baxter Healthcare Hillrom VOLARA System P.CIRCUIT 5KIT AC recall — FDA Z-2551-2026
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…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 8, 2026
Baxter Healthcare Hillrom VOLARA System P.CIRCUIT KIT recall — FDA Z-2548-2026
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…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 8, 2026
Baxter Healthcare Hillrom VOLARA P.CIRCUIT 5KIT recall — FDA Z-2549-2026
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…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJun 10, 2026
Exacta Mix Vented Micro-Volume Inlet recall — FDA Z-2262-2026
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceApr 8, 2026
Baxter Healthcare Blue Ventilator Adapter Module, single-patient use circuit, Product Code recall — FDA Z-1637-2026
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceMar 25, 2026
Welch Allyn Spot Vision Screener VS100 recall — FDA Z-1573-2026
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJan 28, 2026
Baxter Healthcare SIGMA Spectrum Infusion Pump recall — FDA Z-1121-2026
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceDec 10, 2025
Baxter Healthcare Welch Allyn INF BAG, Thigh 1-Tube recall — FDA Z-0847-2026
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 29, 2025
Baxter Healthcare Oral Probe (Product code 02893-000), accessory used with Welch Allyn recall — FDA Z-0233-2026
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve recall — FDA Z-0190-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK recall — FDA Z-0194-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter recall — FDA Z-0195-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard recall — FDA Z-0198-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK recall — FDA Z-0193-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK recall — FDA Z-0202-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code recall — FDA Z-0204-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 22, 2025
Baxter Healthcare CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing recall — FDA Z-0203-2026
IV sets may leak.
Class IIFDA: OngoingBaxter Healthcare Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Baxter Healthcare Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.