Brand
Carefusion 213, Llc Recalls
32 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Carefusion 213, Llc.
32Total Recalls
13Critical
152.1MUnits Affected
Apr 22, 2026Most Recent
All Recalls
Every Carefusion 213, Llc Recall
Sorted by most recent. Click any recall for full details.
32 recalls
High RiskFDA
Carefusion 213, Llc
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x...
Drugs0 affectedApr 22, 2026
High RiskFDA
Carefusion 213, Llc
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per ...
Drugs0 affectedApr 22, 2026
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFu...
Drugs106,400 affectedDec 17, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Ste...
Drugs385,200 affectedMay 15, 2025
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin ...
Drugs205,440 affectedFeb 14, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 ap...
Drugs398,160 affectedAug 25, 2023
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution...
Drugs707,050 affectedApr 20, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs11,115,774 affectedMar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs952,100 affectedMar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs7,990,100 affectedMar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs1,434,000 affectedMar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs14,275,400 affectedMar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs24,969,700 affectedMar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs6,869,400 affectedMar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs40,720,900 affectedMar 19, 2021
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs36 affectedJul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs988 affectedJul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ...
Drugs400 affectedJul 7, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs280 affectedJul 7, 2020
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 app...
Drugs2,800,800 affectedJun 23, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Appl...
Drugs12,500 affectedJun 23, 2020
CriticalFDA
Carefusion 213, Llc
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Pa...
Drugs4,272,300 affectedJun 23, 2020
High RiskFDA
Carefusion 213, Llc
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
Drugs20,556,000 affectedOct 24, 2014
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Onl...
Drugs23,000 affectedJun 13, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0...
Drugs8,960,000 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
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 ...
Drugs46,500 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
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...
Drugs698,000 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
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...
Drugs544,500 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
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-coun...
Drugs3,032,000 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
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...
Drugs929,000 affectedMar 4, 2013
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators...
Drugs576 affectedApr 23, 2012
High RiskFDA
Carefusion 213, Llc
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 26...
Drugs67,775 affectedNov 8, 2011