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.

26–48 of 48

SevereFDA (Drugs)·D-0345-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0348-2021·2021-05-05
ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0349-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0350-2021·2021-05-05
CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk
CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.
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
HighFDA (Drugs)·D-0347-2021·2021-05-05
ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0266-2021·2021-03-03
CareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk
CareFusion 213, LLC is recalling non-sterile ChloraPrep With Tint solution distributed in Puerto Rico and Oman due to potential fungal contamination.
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, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0267-2021·2021-03-03
CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0268-2021·2021-03-03
FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk
CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0265-2021·2021-03-03
FDA Recalls Chloraprep One-Step Due to Potential Fungal Growth
CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-1510-2020·2020-08-26
CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility
CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.
Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Category
Medical Device
Distribution
2 states
CriticalFDA (Drugs)·D-1509-2020·2020-08-26
FDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility
CareFusion 213, LLC is recalling 12,500 units of Chloraprep One-Step applicators because they are not sterile and contain Aspergillus Penicilloides.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-1511-2020·2020-08-26
CareFusion Chlorhexidine Applicators Recalled for Non-Sterility
CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.
Product
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Category
Medical Device
Distribution
2 states
ModerateFDA (Drugs)·D-0298-2015·2014-12-17
CareFusion Recalls Chlorhexidine Gluconate Surgical Hand Scrub for Concentration Issues
CareFusion 213, LLC is recalling Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, because it contains higher concentrations of available chlorhexidine gluconate than required.
Product
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1442-2014·2014-07-23
CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-227-2013·2013-04-03
CareFusion Blood Culture Prep Kits Recalled for Misleading Sterility Labeling
CareFusion is recalling Blood Culture Prep Kit II units because the product is not sterile, making the labeling misleading regarding sterility claims.
Product
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-224-2013·2013-04-03
CareFusion Recalls Misbranded Isopropanol Applicators Due to Sterility Labeling
CareFusion 213, LLC is recalling 698,000 SEPP 70% Isopropanol applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
Product
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-228-2013·2013-04-03
CareFusion Recalls Donor Prep Kits Due to Misleading Sterility Labeling
CareFusion 213, LLC is recalling 46,500 Donor Prep Kits because the labeling is misleading regarding sterility claims. The product is not sterile.
Product
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-229-2013·2013-04-03
CareFusion Recalls FREPP/SEPP Kits Due to Misleading Sterility Labeling
CareFusion 213, LLC is recalling 544,500 FREPP/SEPP kits because the product is not sterile, but the labeling misleadingly implies it is.
Product
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-226-2013·2013-04-03
CareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors
CareFusion is recalling SEPP 10% Povidone Iodine Solution applicators because the product is not sterile, making the sterility claims on the label misleading.
Product
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 2606
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-225-2013·2013-04-03
CareFusion Recalls SEPP 2% Iodine Tincture Applicators for Sterility Mislabeling
CareFusion 213, LLC is recalling SEPP 2% Iodine Tincture applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
Product
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1001-2013·2013-04-03
CareFusion Recalls Preoperative Skin Prep Products Due to Sterility Labeling Error
CareFusion is recalling Sepp Compound Benzoin Tincture products because labeling incorrectly implies the antiseptic solution is sterile, when only the applicator is sterile.
Product
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-004-2013·2012-10-10
Carefusion Recalls ChloraPrep Skin Preparation Due to Sterility Failure
Carefusion 213, LLC is recalling ChloraPrep One-Step skin preparation applicators because quarantined material failed sterility testing. The affected product was distributed in Illinois, Missouri, and New Jersey.
Product
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1674-2012·2012-09-26
Carefusion Recalls ChloraPrep Applicators Due to Incomplete Seals
Carefusion is recalling 67,775 ChloraPrep with Tint applicators because some units had incomplete seals, potentially compromising sterility.
Product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Category
Medical Device
Distribution
Distributed nationwide