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Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 8, 2016Medical DevicesFDA
Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemo
Hazard: Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
June 8, 2016Medical DevicesFDA
Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemo
Hazard: Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
June 8, 2016Medical DevicesFDA
Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemos
Hazard: Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
June 1, 2016DrugsFDA
Baxter Healthcare Corp. recalls CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection
Hazard: Presence of Particulate Matter: identified as dried skin.
June 1, 2016DrugsFDA
Baxter Healthcare Corp. recalls Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA,
Hazard: Presence of Particulate Matter: identified as a cloth fiber.
June 1, 2016DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter
Hazard: Presence of Particulate Matter: identified as cardboard.
June 1, 2016DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter
Hazard: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
May 18, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER D
Hazard: Instructions for use booklet may puncture the outer Tyvek lid.
May 18, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Dev
Hazard: Instructions for use booklet may puncture the outer Tyvek lid.
May 18, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER D
Hazard: Instructions for use booklet may puncture the outer Tyvek lid.
May 18, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER
Hazard: Instructions for use booklet may puncture the outer Tyvek lid.
May 18, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER D
Hazard: Instructions for use booklet may puncture the outer Tyvek lid.
May 18, 2016DrugsFDA
Baxter Healthcare Corp. recalls Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL,
Hazard: Discoloration: presence of atypical yellow discoloration of the solution .
May 4, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls Automated peritoneal dialysis (APD) cycler
Hazard: Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
March 9, 2016DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produc
Hazard: PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
January 13, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C868
Hazard: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
January 13, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Produc
Hazard: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
January 13, 2016Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a cont
Hazard: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
November 25, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pe
Hazard: Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
November 11, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Hazard: Leakage from the inlet port of the 15L Cycler Drainage Bags.
October 28, 2015Medical DevicesFDA
Baxter Healthcare Corp recalls ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Hazard: Potential for a leak at the tubing to luer bond.
September 30, 2015DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcar
Hazard: Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
September 2, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEA
Hazard: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
September 2, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter fo
Hazard: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
September 2, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locki
Hazard: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
September 2, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with
Hazard: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
August 26, 2015DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, De
Hazard: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
August 26, 2015DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter H
Hazard: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
August 19, 2015DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 600
Hazard: Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
July 15, 2015DrugsFDA
Baxter Healthcare Corp. recalls Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Stat
Hazard: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)