The Recall Desk

Manufacturer

CareFusion 213, LLC

48 recalls in our database name CareFusion 213, LLC as the manufacturing or recalling firm.

What the numbers show

Total
48
Critical
6
Severe
28
Most recent
2026-07-22

Of the 48 recalls from CareFusion 213, LLC we have scored against our rubric, 6 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (58%) 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.

1–25 of 48

  • SevereFDA (Drugs)·D-0690-2026·2026-07-22

    ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2026·2026-07-08

    PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall

    CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0650-2026·2026-07-08

    ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0651-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

    CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization

    CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0648-2026·2026-07-08

    ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance

    CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0649-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0646-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0624-2026·2026-07-01

    ChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0625-2026·2026-07-01

    ChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns

    CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2026·2026-07-01

    ChloraPrep One-Step Topical Solution Sterility Assurance Recall

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0622-2026·2026-07-01

    ChloraPrep One-Step antiseptic solution sterility assurance recall

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal area, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0518-2026·2026-05-13

    BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall

    CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0517-2026·2026-05-13

    PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance

    CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0243-2026·2026-01-07

    ChloraPrep triple swabsticks recalled over lack of assurance of sterility

    CareFusion 213 is recalling 106,400 units of BD ChloraPrep Triple Swabsticks over a lack of assurance of sterility.

    Product
    CHLORAPREP SWABSTICK — CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0441-2025·2025-05-28

    ChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because affected units may have open seals on the packaging, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2025·2025-03-19

    ChloraPrep One-Step Topical Drug Recalled for Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step, a preoperative skin preparation drug, due to non-sterility from a package lidding breach allowing fungal contamination. The recall affects 205,440 applicators distributed nationwide and in Canada.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1168-2023·2023-09-27

    ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims

    BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0373-2021·2021-05-19

    Chloraprep One-Step Applicator Recalled for Loose Endcap Releasing Glass Shards

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators because the endcap may fall off during activation, releasing glass shards into the solution.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

    CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide