Carefusion 213 recalls
Carefusion 213 appears in 48 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 48 |
|---|---|
| Published | 2012-09-26 to 2026-07-22 |
| By agency | FDA Drug (47), FDA Device (1) |
| By classification | Class II (31), Class I (15), Class III (2) |
| By status | terminated (27), ongoing (20), completed (1) |
| Distribution named in notices | IL, MO, NJ, PR, US |
Recalls
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) e…
FDA Drug · Class II · 2026-07-22 · Carefusion 213
Reason: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/cas…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUT…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, Ca…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION,…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case,…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case,…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL appl…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/c…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTI…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/ca…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Ste…
FDA Drug · Class I · 2026-07-01 · Carefusion 213
Reason: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Sol…
FDA Drug · Class II · 2026-07-01 · Carefusion 213
Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Ste…
FDA Drug · Class II · 2026-07-01 · Carefusion 213
Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner C…
FDA Drug · Class I · 2026-07-01 · Carefusion 213
Reason: Non-Sterility: Due to presence of Aspergillus penicillioides. - 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 2…
FDA Drug · Class II · 2026-05-13 · Carefusion 213
Reason: Lack of assurance of Sterility: potential product contamination - BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per ca…
FDA Drug · Class II · 2026-05-13 · Carefusion 213
Reason: Lack of assurance of Sterility: potential product contamination - BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusi…
FDA Drug · Class II · 2026-01-07 · Carefusion 213
Reason: Lack of Assurance of Sterlity - BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Steri…
FDA Drug · Class II · 2025-05-28 · Carefusion 213
Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. - BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Pr…
FDA Drug · Class I · 2025-03-19 · Carefusion 213
Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. - BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 appl…
FDA Drug · Class II · 2023-09-27 · Carefusion 213
Reason: Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate… - BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution,…
FDA Drug · Class I · 2021-05-19 · Carefusion 213
Reason: Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution. - ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 f…
FDA Drug · Class I · 2021-05-05 · Carefusion 213
Reason: Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach… - 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, 2…
FDA Drug · Class II · 2021-05-05 · Carefusion 213
Reason: Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting… - 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, 2…
FDA Drug · Class I · 2021-05-05 · Carefusion 213
Reason: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. - 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…
FDA Drug · Class II · 2021-05-05 · Carefusion 213
Reason: CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of… - ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 f…
FDA Drug · Class II · 2021-05-05 · Carefusion 213
Reason: CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of… - 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…
FDA Drug · Class I · 2021-05-05 · Carefusion 213
Reason: Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach… - 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 ml…
FDA Drug · Class II · 2021-05-05 · Carefusion 213
Reason: Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting… - 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 ml…
FDA Drug · Class I · 2021-05-05 · Carefusion 213
Reason: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. - ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 f…
FDA Drug · Class I · 2021-03-03 · Carefusion 213
Reason: Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is t… - 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 ml…
FDA Drug · Class I · 2021-03-03 · Carefusion 213
Reason: Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Asperg… - 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, 2…
FDA Drug · Class I · 2021-03-03 · Carefusion 213
Reason: Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Asperg… - 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…
FDA Drug · Class I · 2021-03-03 · Carefusion 213
Reason: Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is t… - BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applic…
FDA Drug · Class I · 2020-08-26 · Carefusion 213
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides - ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso…
FDA Drug · Class I · 2020-08-26 · Carefusion 213
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides - ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applic…
FDA Drug · Class I · 2020-08-26 · Carefusion 213
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides - Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
FDA Drug · Class III · 2014-12-17 · Carefusion 213
Reason: Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate. - ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange
FDA Drug · Class II · 2014-07-23 · Carefusion 213
Reason: Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed. - 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…
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - 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…
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk
FDA Device · Class III · 2013-04-03 · Carefusion 213
Reason: An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does… - 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,…
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - 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 k…
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.6…
FDA Drug · Class II · 2013-04-03 · Carefusion 213
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. - ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators,…
FDA Drug · Class II · 2012-10-10 · Carefusion 213
Reason: Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing. - ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 2604…
FDA Drug · Class II · 2012-09-26 · Carefusion 213
Reason: Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.