Baxter Healthcare Corporation: 207 recalls on record

Recalls filed with 1 agency: FDA (207).

First recall on record: June 20, 2012. Most recent: September 16, 2026.

Risk classification: Class I: 36 · Class II: 164 · Class III: 7

Most recent recalls

DateAgencyProduct
November 13, 2019FDAPrismaflex Control Unit, software versions below 7.21Z-0277-2020
November 13, 2019FDAPrismaflex Control Unit, software versions below 7.21Z-0276-2020
November 13, 2019FDAPrismaflex Control Unit, software versions below 7.21Z-0279-2020
November 6, 2019FDATherMax Blood Warmer UnitZ-0247-2020
October 9, 2019FDAL5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. S…Z-0030-2020
July 10, 2019FDAREVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzer…Z-1909-2019
November 14, 2018FDAMetoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use gla…D-0222-2019
October 24, 2018FDASPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009Z-0107-2019
October 3, 2018FDALevofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), …D-1215-2018
September 5, 2018FDA0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation De…D-1128-2018
August 15, 2018FDALevofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 …D-1034-2018
August 15, 2018FDALevofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 10…D-1035-2018
August 15, 2018FDALevofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 15…D-1036-2018
June 13, 2018FDABaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, …Z-2113-2018
May 30, 2018FDABaxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400…Z-1909-2018
May 30, 2018FDAPrismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is …Z-1926-2018
May 30, 2018FDAPrismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is i…Z-1922-2018
January 31, 2018FDAMARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541Z-0411-2018
November 1, 2017FDAIntralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius K…D-0030-2018
August 23, 2017FDAHomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The…Z-3041-2017
August 23, 2017FDAHomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The Hom…Z-3040-2017
July 19, 2017FDA0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcar…D-0973-2017
July 19, 2017FDA0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthc…D-0957-2017
July 19, 2017FDA5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare…D-0972-2017
May 24, 2017FDAFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container…D-0788-2017

Questions about this company

How many recalls does Baxter Healthcare Corporation have?
Recalert has 207 U.S. recalls on record for Baxter Healthcare Corporation, published between June 20, 2012 and September 16, 2026.
Which agencies have handled Baxter Healthcare Corporation recalls?
Baxter Healthcare Corporation appears as the recalling firm in recalls from: FDA (207).

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