The Recall Desk

Manufacturer

Baxter Healthcare Corporation

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

What the numbers show

Total
432
Critical
9
Severe
88
Most recent
2026-09-09

Of the 432 recalls from Baxter Healthcare Corporation we have scored against our rubric, 9 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 88 (20%) 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.

176–200 of 432

  • HighFDA (Devices)·Z-1377-2024·2024-04-03

    Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use

    Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.

    Product
    Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1380-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin

    Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1379-2024·2024-04-03

    Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery

    Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.

    Product
    Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1329-2024·2024-03-27

    Hip Traction Boot Assembly Defect Could Cause Device Detachment

    Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.

    Product
    HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2024·2024-03-20

    STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk

    Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.

    Product
    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2024·2024-03-20

    CLEARLINK Solution Set Adapter recalled for potential drip chamber leaks

    Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.

    Product
    CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1001-2024·2024-02-28

    Baxter Exactamix Pro 1200 Software Error Causes Medication Over-delivery

    Baxter Healthcare is recalling the Baxter Exactamix Pro 1200 medication compounding device due to a software error that may cause ingredient over-delivery when using the 'Use Some Overfill' feature.

    Product
    Baxter Exactamix Pro 1200, REF EXM12DY
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Drugs)·D-0336-2024·2024-02-28

    Intravenous norepinephrine drug recalled for incorrect concentration labeling

    Baxter Healthcare is recalling 13,000 bags of norepinephrine bitartrate injection due to an overwrap label incorrectly showing 4 mg/250 mL concentration, while the primary bag label correctly shows the actual 8 mg/250 mL strength.

    Product
    NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2024·2024-01-17

    Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure

    Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.

    Product
    Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2024·2024-01-17

    Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information

    Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.

    Product
    Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2024·2024-01-17

    Cardiac Stress Testing Device May Produce Distorted ECG Readings

    The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.

    Product
    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT Q
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0705-2024·2024-01-17

    Cardiac Stress Testing System may produce distorted electrocardiogram readings

    The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.

    Product
    Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0706-2024·2024-01-17

    XScribe Cardiac Stress Testing System may distort ECG readings

    Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.

    Product
    XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
    Category
    Medical Device
    Distribution
    2 states
  • 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-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-0668-2024·2024-01-17

    Baxter PERI-GUARD SUPPLE marketing brochure contains inaccurate instructions

    Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.

    Product
    PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0656-2024·2024-01-17

    Baxter Flo-Rester Vessel Occluder Recall Due to Inaccurate Marketing Brochure

    Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.

    Product
    Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0663-2024·2024-01-17

    Baxter Flo-Thru Intraluminal Shunt recalled for marketing brochure inaccuracy

    Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.

    Product
    Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.
    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-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-0658-2024·2024-01-17

    Medical Device Recall: Baxter Ostene Hemostasis Material Marketing Brochure Inaccuracy

    Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.

    Product
    Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 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-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

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.