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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

193

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 181–193 of 193 recalls

Baxter Healthcare Corporation: Infusion Pump

Battery performance issues related to prolonged storage.

Moderate

FDAJan 6, 2021AL, AK, AZ +49 more• Baxter Healthcare Corporation

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

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Moderate

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Single Needle Conversion Kit, product co...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Moderate

FDADec 30, 2020Nationwide

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Page 10 of 10Next

• Baxter Healthcare Corporation

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

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Moderate

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

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

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Moderate

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Gambro Cartridge Blood Set Prime Line, product code 10102...

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Moderate

FDADec 30, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 s...

Potential for the battery to lose its ability to be recharged.

Moderate

FDADec 28, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Libr...

There is a potential software error during programming.

Moderate

FDANov 23, 2020Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: Baxter Spectrum IQ Infusion System with Dose IQ Safety So...

There is a potential software error during programming.

Moderate

FDANov 23, 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.

Moderate

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

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

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.

Moderate

FDADec 12, 2019Nationwide• Baxter Healthcare Corporation

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

Moderate

FDADec 12, 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.

Moderate

FDAOct 4, 2019Nationwide• Baxter Healthcare Corporation