The Recall Desk

Manufacturer

Baxter Healthcare Corporation

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

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.

76–100 of 279

  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0567-2025·2024-12-04

    Baxter MiniCap PD Transfer Set Recalled for Female Connector Separation

    Baxter Healthcare is recalling 1,496 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation. The affected lots should not be used until assessed by Baxter.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0566-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints

    Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0563-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0565-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set: Female Connector Separation Risk

    Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0561-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set due to reports of connector separation that could interrupt dialysis treatment. The recall affects 31,248 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0564-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0568-2025·2024-12-04

    Baxter Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0569-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0559-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0560-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0382-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure

    Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0379-2025·2024-11-27

    Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2025·2024-11-27

    Baxter peritoneal dialysis transfer set recalled for PCB exposure risk

    Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure

    Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0377-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2025·2024-11-27

    Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2025·2024-11-20

    Baxter Spectrum IQ Infusion Pump Door May Not Close Fully

    Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0322-2025·2024-11-13

    Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams

    The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.

    Product
    Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0323-2025·2024-11-13

    Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

    Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

    Product
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0320-2025·2024-11-13

    Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk

    Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.

    Product
    Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0324-2025·2024-11-13

    Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall

    Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.

    Product
    Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0321-2025·2024-11-13

    Cardiac stress testing system recalled due to duplicate patient identifiers

    The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.

    Product
    Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
    Category
    Medical Device
    Distribution
    0 states