Baxter Healthcare Corporation

143 FDA enforcement actions

143 Total Recalls

37 Class I

105 Class II

1 Class III

Firm Details

Product Types: drug, device
States: IL

All Recalls

Class II: Risk 12/22/2025 drug

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class II: Risk 11/28/2025 device

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 having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Class II: Risk 10/28/2025 device

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 II: Risk 09/17/2025 device

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 lead to a delay in managing fever-related symptoms or infection.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/29/2025 device

IV sets may leak.
Class II: Risk 08/20/2025 drug

Discoloration
Class II: Risk 08/08/2025 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Class I: Dangerous 08/04/2025 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Class I: Dangerous 08/04/2025 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Class I: Dangerous 08/04/2025 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Class I: Dangerous 07/14/2025 device

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
Class II: Risk 07/14/2025 device

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Class I: Dangerous 06/20/2025 device

Certain Spectrum infusion pumps may have an incorrect version of software.
Class I: Dangerous 06/20/2025 device

Certain Spectrum infusion pumps may have an incorrect version of software.
Class I: Dangerous 05/30/2025 device

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Class I: Dangerous 05/30/2025 device

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Class II: Risk 05/12/2025 device

Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
Class II: Risk 05/09/2025 device

The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Class II: Risk 05/06/2025 device

There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Class I: Dangerous 04/24/2025 device

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Class I: Dangerous 04/07/2025 device

A cybersecurity vulnerability was discovered through internal testing.
Class I: Dangerous 04/07/2025 device

A cybersecurity vulnerability was discovered through internal testing.
Class II: Risk 03/24/2025 device

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class II: Risk 03/24/2025 device

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class II: Risk 03/24/2025 device

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/21/2025 device

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Class II: Risk 03/03/2025 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class II: Risk 02/25/2025 device

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Class I: Dangerous 02/05/2025 device

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Class I: Dangerous 02/05/2025 device

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Class I: Dangerous 12/20/2024 device

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Class II: Risk 12/20/2024 device

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Class I: Dangerous 12/20/2024 device

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Class II: Risk 12/20/2024 device

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Class II: Risk 12/20/2024 device

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Class I: Dangerous 12/20/2024 device

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Class I: Dangerous 12/20/2024 device

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Class II: Risk 11/19/2024 device

Devices were identified as released after repair without full testing being performed, which includes flow testing.
Class II: Risk 11/19/2024 device

Devices were identified as released after repair without full testing being performed, which includes flow testing.
Class II: Risk 10/30/2024 drug

Labeling: Missing Label
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class II: Risk 10/23/2024 device

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/21/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class I: Dangerous 10/16/2024 device

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/11/2024 device

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Class II: Risk 10/02/2024 device

The door on the Spectrum IQ Infusion pump may not be able to fully close.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/19/2024 device

The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Class II: Risk 09/18/2024 device

The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
Class I: Dangerous 09/12/2024 device

The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
Class I: Dangerous 08/20/2024 device

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I: Dangerous 08/20/2024 device

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I: Dangerous 08/20/2024 device

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I: Dangerous 08/20/2024 device

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Class I: Dangerous 08/01/2024 drug

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II: Risk 07/17/2024 device

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Class II: Risk 07/17/2024 device

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Class II: Risk 06/28/2024 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.
Class II: Risk 06/17/2024 drug

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II: Risk 06/14/2024 device

Improperly performed testing prior to release
Class II: Risk 06/13/2024 device

The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
Class II: Risk 06/04/2024 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
Class II: Risk 06/04/2024 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
Class II: Risk 06/04/2024 device

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
Class II: Risk 06/03/2024 device

During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
Class I: Dangerous 05/30/2024 device

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class I: Dangerous 05/30/2024 device

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class I: Dangerous 05/29/2024 device

Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
Class II: Risk 05/08/2024 device

There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Class II: Risk 01/23/2024 drug

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II: Risk 11/14/2023 drug

Failed pH Specifications
Class II: Risk 08/24/2023 drug

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class III: Low Risk 08/14/2023 drug

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class II: Risk 08/11/2023 drug

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II: Risk 08/11/2023 drug

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II: Risk 03/15/2023 drug

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II: Risk 03/15/2023 drug

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II: Risk 08/04/2022 drug

Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.