The Recall Desk

Manufacturer

Carefusion 2200 Inc

112 recalls in our database name Carefusion 2200 Inc as the manufacturing or recalling firm.

What the numbers show

Total
112
Critical
0
Severe
2
Most recent
2023-08-23

Of the 112 recalls from Carefusion 2200 Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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.

76–100 of 112

  • HighFDA (Devices)·Z-0216-2023·2022-11-23

    Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.

    Product
    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
    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
  • HighFDA (Devices)·Z-0209-2023·2022-11-23

    CareFusion sterilization containers fail aerosol challenge testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0212-2023·2022-11-23

    CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing

    CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
    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
  • HighFDA (Devices)·Z-2646-2020·2020-07-29

    Carefusion Thora-Para Catheter Drainage Tray Recalled for Valve Leakage

    Carefusion 2200 Inc is recalling Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2658-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled for Internal Valve Leakage

    Carefusion 2200 Inc is recalling Safe-T 5 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2656-2020·2020-07-29

    Carefusion Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray Recalled

    Carefusion 2200 Inc is recalling Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2655-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled Due to Potential Air Leak

    Carefusion 2200 Inc is recalling Safe-T 8 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2400-2020·2020-06-24

    Becton Dickinson Recalls Mueller Knife Handles Due to Machining Burr

    Becton Dickinson is voluntarily recalling Mueller Knife Handles because a machining burr on the collet threads may prevent the blade from seating securely.

    Product
    Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2018·2018-04-25

    Carefusion Recalls Jamshidi Needles Due to Compromised Sterile Packaging

    Carefusion 2200 Inc is recalling 14,200 Jamshidi (TJ) needles because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2018·2018-04-25

    Carefusion 2200 Recalls Jamshidi Bone Marrow Needles Due to Packaging Integrity

    Carefusion 2200 Inc is recalling sterile Jamshidi bone marrow needles because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide