Home / Brands / Baxter Healthcare
Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex System, Prismaflex Control Unit
Hazard: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
April 15, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally en
Hazard: 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
April 15, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and art
Hazard: 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
April 15, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and ar
Hazard: 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
March 11, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Hazard: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
January 15, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N
Hazard: 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.
January 15, 2020Medical DevicesFDA
Baxter Healthcare Corporation recalls Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the adm
Hazard: 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.
November 27, 2019DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-
Hazard: Lack of Assurance of Sterility: Product has the potential to leak.
November 13, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex Control Unit, software versions below 7.21
Hazard: 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.
November 13, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex Control Unit, software versions below 7.21
Hazard: 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.
November 13, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex Control Unit, software versions below 7.21
Hazard: 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.
November 13, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex Control Unit, software versions below 7.21
Hazard: 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.
November 13, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Prismaflex Control Unit, software versions below 7.21
Hazard: 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.
November 6, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls TherMax Blood Warmer Unit
Hazard: 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.
October 30, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL;
Hazard: Potential ability to leak once used for compounding.
October 16, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (
Hazard: Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
October 9, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Hazard: Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.
September 4, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONT
Hazard: EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
July 31, 2019DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 6001
Hazard: Lack of Assurance of Sterility: Bags have potential to leak.
July 10, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment o
Hazard: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
July 10, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment o
Hazard: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
June 19, 2019DrugsFDA
Baxter Healthcare Corporation recalls Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield
Hazard: Failed Stability Specifications
May 8, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Bax
Hazard: The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
February 27, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solutio
Hazard: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
February 27, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution
Hazard: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
January 16, 2019DrugsFDA
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only
Hazard: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
January 2, 2019Medical DevicesFDA
Baxter Healthcare Corporation recalls GEM Coupler Forceps, GEM4183C, packaged individually.
Hazard: Potential presence of rust on Coupler Forceps (GEM4183C).
November 14, 2018DrugsFDA
Baxter Healthcare Corporation recalls Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured
Hazard: Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
November 7, 2018Medical DevicesFDA
Baxter Healthcare Corporation recalls EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be
Hazard: Potential ability to leak once used for compounding.
November 7, 2018Medical DevicesFDA
Baxter Healthcare Corporation recalls EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be
Hazard: Potential ability to leak once used for compounding.