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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

260

Past Year

Class I (Serious)

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 221–240 of 260 recalls

Baxter Healthcare Corporation: Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter is updating the device IFU for safety communication regarding cleaning practices.

FDAJun 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Flow Coupler Monitor, GEM, Global Excellence Microsurgery...

A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

FDAJun 2, 2020AZ, CA, FL +16 more• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Low Weight-Low Volume Blood Transport Sy...

Potential disconnection of tubing set.

FDAApr 17, 2020Nationwide

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• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Set Prime Line - Product Usage: is...

Potential disconnection of tubing set.

FDAApr 17, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Low Volume Blood Transport System for He...

Potential disconnection of tubing set.

FDAApr 17, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Transport System for Hemodialysis ...

Potential disconnection of tubing set.

FDAApr 17, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex Control Unit

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

FDAApr 7, 2020PR• Baxter Healthcare Corporation

Baxter Healthcare Corporation: GEM Microvascular Anastomotic Coupler Devices - Product U...

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

FDAMar 5, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex System, Prismaflex Control Unit

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

FDAFeb 6, 2020IN, PR• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Clearlink System Continu-Flo Administration Sets, Product...

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

FDADec 12, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: ONE-LINK Needle-free IV Connector, Product Codes: 7N8300,...

FDADec 12, 2019Nationwide• Baxter Healthcare Corporation

Sodium Chloride Irrigation (Baxter) – Sterility Risk (2019)

Lack of Assurance of Sterility: Product has the potential to leak.

Class IIModerate

FDANov 19, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Revaclear Capillary Dialyzer 300, REF Revaclear 300 Produ...

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

FDANov 15, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

FDAOct 4, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: TherMax Blood Warmer Unit

TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.

FDASep 19, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with...

Potential ability to leak once used for compounding.

FDASep 18, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK,...

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

FDAAug 13, 2019Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (Baxter) – Sterility Risk (2019)

Lack of Assurance of Sterility: Bags have potential to leak.

Class IIModerate

FDAJul 18, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, R...

EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

FDAJun 27, 2019Nationwide• Baxter Healthcare Corporation

Sevoflurane (Baxter Healthcare) – stability specification failure (2019)

Failed Stability Specifications

Class IIModerate

FDAJun 13, 2019Nationwide• Baxter Healthcare Corporation