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Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 28, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Hazard: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
December 28, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Hazard: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
December 28, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal fa
Hazard: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
December 28, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Hazard: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
November 23, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hill-Rom Progressa Bed System
Hazard: The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distra
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the pat
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Hazard: the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part
Hazard: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Num
Hazard: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0
Hazard: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0
Hazard: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
November 9, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193,
Hazard: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
October 19, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement thera
Hazard: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
October 19, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in pr
Hazard: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
October 19, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid m
Hazard: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
October 19, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement t
Hazard: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
October 19, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid managem
Hazard: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
October 5, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/sp
Hazard: Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
September 21, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Hazard: Firm noted an increase in customer reports of leaks.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
August 31, 2022Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100
Hazard: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.