The Recall Desk

Manufacturer

Carefusion 2200 Inc

80 recalls in our database name Carefusion 2200 Inc 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.

76–80 of 80

  • HighFDA (Devices)·Z-0213-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Validation Testing

    CareFusion GENESIS sterilization containers have failed aerosol challenge testing for STERRAD sterilization validation. The recall affects 451 units distributed in the US and 17 other countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0217-2023·2022-11-23

    CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements

    Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.

    Product
    CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2023·2022-11-23

    CareFusion Genesis Mini Sterilization Containers fail aerosol testing

    CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.

    Product
    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0833-2022·2022-04-06

    CareFusion Endoscopic Equipment Recalled for Missing Instructions for Use

    CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.

    Product
    (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, S
    Category
    Medical Device
    Distribution
    Distributed nationwide