The Recall Desk

Manufacturer

Baxter Healthcare Corp.

144 recalls in our database name Baxter Healthcare Corp. as the manufacturing or recalling firm.

What the numbers show

Total
144
Critical
18
Severe
30
Most recent
2017-09-20

Of the 144 recalls from Baxter Healthcare Corp. we have scored against our rubric, 18 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (21%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 144

  • HighFDA (Devices)·Z-3133-2017·2017-09-20

    Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues

    Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.

    Product
    Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0672-2017·2016-12-07

    Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies

    Baxter Healthcare is recalling 439 V6 Rear Case Assemblies for SIGMA Spectrum Infusion Pumps because the speakers may fail prematurely.

    Product
    V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible ton
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2017·2016-12-07

    Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk

    Baxter Healthcare is recalling 5,976 Sigma Spectrum Infusion Pumps because some speakers may fail prematurely, potentially affecting audible alarms.

    Product
    sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly loca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0671-2017·2016-12-07

    Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure

    Baxter is recalling SIGMA Spectrum Infusion Pumps to replace speakers that may fail prematurely, potentially affecting audible alarm tones.

    Product
    Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2017·2016-11-16

    Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter

    Baxter Healthcare is recalling 22,656 Revaclear MAX dialyzers because of potential particulate matter on the blood side of the device.

    Product
    GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2687-2016·2016-09-07

    Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise

    Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.

    Product
    Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-2609-2016·2016-08-31

    Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect

    Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.

    Product
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2533-2016·2016-08-24

    Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports

    Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2016·2016-07-06

    Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks

    Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.

    Product
    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Drugs)·D-0957-2016·2016-06-15

    Baxter Recalls Sodium Chloride Injection Due to Insect Particulate Matter

    Baxter Healthcare is recalling 255,852 bags of 0.9% Sodium Chloride Injection because customers reported finding an insect in the primary container.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0958-2016·2016-06-15

    Baxter Recalls Dextrose Injection Due to Insect Contamination

    Baxter Healthcare is recalling Dextrose Injection, USP, 70% due to confirmed reports of an insect found in the primary container.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0864-2016·2016-06-01

    Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter

    Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0863-2016·2016-06-01

    Baxter Recalls Metronidazole Injection Bags Due to Cloth Fiber Particulate Matter

    Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP due to the presence of a cloth fiber. The product was distributed nationwide and in Puerto Rico.

    Product
    METRONIDAZOLE — METRONIDAZOLE (METRONIDAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2016·2016-06-01

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2016·2016-05-18

    Baxter GEM Flowcoupler Recall Due to Packaging Puncture Risk

    Baxter Healthcare is recalling 315 units of GEM Flowcoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2016·2016-05-18

    Baxter Recalls Brevibloc Injection Due to Yellow Discoloration

    Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.

    Product
    BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 630 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2016·2016-05-18

    Baxter GEM FlowCoupler Recalled Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 118 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2016·2016-05-18

    Baxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk

    Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1629-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 707 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1565-2016·2016-05-04

    Baxter APD Cycler Recall for Incomplete Clinician Guide Instructions

    Baxter Healthcare is recalling 10 automated peritoneal dialysis cyclers because the clinician guide lacks instructions for priming the patient line.

    Product
    Automated peritoneal dialysis (APD) cycler
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Baxter Healthcare Corporation

business enterprise in United States of America

Country
United States

Source: Wikidata (Q45134864), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.

Baxter Healthcare Corp. recalls · The Recall Desk