The Recall Desk

Manufacturer

Baxter Healthcare Corporation

439 recalls in our database name Baxter Healthcare Corporation as the manufacturing or recalling firm.

What the numbers show

Total
439
Critical
10
Severe
100
Most recent
2026-10-21

Of the 439 recalls from Baxter Healthcare Corporation we have scored against our rubric, 10 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 100 (23%) 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.

201–225 of 439

  • ModerateFDA (Devices)·Z-0657-2024·2024-01-17

    Baxter Coseal Premix Surgical Sealant: Marketing Brochure Information Inaccuracy

    Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.

    Product
    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0666-2024·2024-01-17

    Cardiovascular Surgical Patch Marketing Brochure Contains Inaccurate Information

    Baxter is recalling marketing materials for Vascu-Guard Peripheral Vascular Patch because a brochure contains inaccurate information that conflicts with the product's official instructions and prescribing information.

    Product
    Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2024·2024-01-17

    Marketing brochure for Baxter Floseal hemostatic device contains inaccurate content

    Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.

    Product
    Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2024·2024-01-17

    Peri-Guard Repair Patch marketing brochure contains inaccurate information

    Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.

    Product
    Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0659-2024·2024-01-17

    Baxter Vascular Probe Marketed with Inaccurate Prescribing Information

    Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.

    Product
    Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2024·2024-01-17

    Baxter FloSeal Hemostatic Matrix brochure contains inaccurate clinical information

    A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2024·2024-01-17

    Baxter FloSeal Hemostatic Matrix Recalled for Marketing Brochure Inaccuracies

    Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0665-2024·2024-01-17

    Peri-Guard Repair Patch Recall Due to Inaccurate Marketing Brochure

    Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.

    Product
    Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2024·2023-12-20

    Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures

    Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.

    Product
    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0146-2024·2023-12-13

    Baxter Healthcare Injectable Ondansetron Recalled for Failed pH Specifications

    Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0151-2024·2023-11-15

    Novum IQ Syringe Pump may falsely indicate infusion completion

    Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.

    Product
    Novum IQ Syringe infusion system, Product Code 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2024·2023-11-08

    Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk

    Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.

    Product
    HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2024·2023-10-25

    Doxil Chemotherapy Drug Recalled for Improper Storage Temperature During Shipment

    Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.

    Product
    DOXIL — DOXIL (DOXORUBICIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2023·2023-10-04

    Baxter Epiphany Cardio Server E3 Caliper Tool Non-Responsive in ECG System

    Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.

    Product
    Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2023·2023-09-20

    Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement

    Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.

    Product
    Welch Allyn Connex Spot Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1141-2023·2023-09-06

    Dianeal Peritoneal Dialysis Solution Recalled for Potential Sterility Compromise

    Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The recall affects 22,112 bags nationwide.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1140-2023·2023-09-06

    DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise

    Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1103-2023·2023-08-30

    Prescription Injection Recalled Due to Missing or Peeled Labels

    Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.

    Product
    BENDAMUSTINE HYDROCHLORIDE — BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2023·2023-07-26

    GEM FLOW COUPLER Monitor LCD Display Fails to Show Correct Active Channel

    Baxter Healthcare is recalling the GEM FLOW COUPLER Monitor due to an LCD display error that may fail to indicate the correct active channel when powered on using battery power. This could lead to incorrect channel selection during use.

    Product
    GEM FLOW COUPLER Monitor, PN 5156-00000-011
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2103-2023·2023-07-19

    Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction

    Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.

    Product
    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2104-2023·2023-07-19

    Spectrum IQ Infusion System False Occlusion Alarm Correction Issued

    The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.

    Product
    The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2023·2023-07-19

    Surgical chest support device recalled for potential cracking at attachment

    Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.

    Product
    Allen Advance Chest Support with Pad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2023·2023-07-05

    Voalte Patient Safety software may fail to alert caregivers of safety changes

    Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.

    Product
    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2023·2023-07-05

    NaviCare Patient Safety software versions recalled for alert suppression defect

    Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.

    Product
    NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1482-2023·2023-05-10

    Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk

    Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.

    Product
    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q)…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.