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Baxter Healthcare Corporation recall records

273 reported ongoing

306 records in this archive. Latest source date Aug 17, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Sep 30, 2022FDA device enforcement

Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902

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).

Class IReported ongoing

Distribution: US

Official source

Sep 30, 2022FDA device enforcement

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901

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).

Class IReported ongoing

Distribution: US

Official source

Sep 20, 2022FDA device enforcement

Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 20, 2022FDA device enforcement

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 20, 2022FDA device enforcement

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 20, 2022FDA device enforcement

Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 20, 2022FDA device enforcement

Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 20, 2022FDA device enforcement

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in...

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.

Class IIReported terminated

Distribution: MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

Official source

Sep 14, 2022FDA device enforcement

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.

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.

Class IIReported ongoing

Distribution: US Nationwide

Official source

Sep 14, 2022FDA device enforcement

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

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.

Class IIReported ongoing

Distribution: US Nationwide

Official source

Sep 14, 2022FDA device enforcement

Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.

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.

Class IIReported ongoing

Distribution: US Nationwide

Official source

Sep 14, 2022FDA device enforcement

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement t...

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.

Class IIReported ongoing

Distribution: US Nationwide

Official source

Sep 14, 2022FDA device enforcement

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

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.

Class IIReported ongoing

Distribution: US Nationwide

Official source

Sep 2, 2022FDA device enforcement

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and...

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

Class IIIReported ongoing

Distribution: US Nationwide Distribution and government/military distribution.

Official source

Aug 9, 2022FDA device enforcement

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Firm noted an increase in customer reports of leaks.

Class IReported terminated

Distribution: US Nationwide Distribution

Official source

Aug 4, 2022FDA drug enforcement

Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfie...

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.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jul 22, 2022FDA device enforcement

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Class IIReported ongoing

Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Official source

Jul 22, 2022FDA device enforcement

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Class IIReported ongoing

Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Official source

Jul 22, 2022FDA device enforcement

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Class IIReported ongoing

Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Official source

Jul 22, 2022FDA device enforcement

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Class IIReported ongoing

Distribution: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Official source

Reasons in these listed records

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

These examples come from this result page and are not a ranking of every recall reason.

Checking Baxter Healthcare Corporation

Is there a recall on baxter healthcare corporation right now?

This archive contains 306 records, including 273 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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