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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

467

Past Year

47

Class I (Serious)

29

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 141–160 of 467 recalls

Baxter Healthcare Corporation: Revaclear 400 Dialyzer. Product Code: 114746L. Used to...

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

FDANov 23, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Revaclear 400 dialyzers. Indicated for treatment of ch...

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

FDANov 23, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Revaclear 300 dialyzers. Indicated for treatment of ch...

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

FDANov 23, 2022Nationwide

1...6 789 10...24

Page 8 of 24Next

• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter Electrocardiograph, ELI 380 -DCS21

One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

FDAOct 31, 2022TX• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Hill-Rom Progressa Bed System

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.

FDAOct 18, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Hillrom Hospital Bed Accessory, Watch Care Incontinence M...

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).

FDASep 30, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Hillrom Centrella Hospital Bed with WatchCare Incontinenc...

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).

FDASep 30, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION ...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-U...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL ...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, RE...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE P...

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.

FDASep 20, 2022MI, TX, WA +1 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex HF20 Set (product code 109841). For use in pr...

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.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex ST Set: ST60 (product code 107643), ST100 (pr...

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.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex M Set: M150 (product code 109990). For use i...

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.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex HF Set: HF1000 (product code 107140), HF1400 ...

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.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex M Set: M60 (product code 106696), M100 (produ...

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.

FDASep 14, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Starling Monitor, Product code CMMST5 and Starling Monito...

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

FDASep 2, 2022Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-V...

Firm noted an increase in customer reports of leaks.

FDAAug 9, 2022Nationwide• Baxter Healthcare Corporation