DrugJul 22, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Clear recall — FDA D-0690-2026
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class IIFDA: OngoingCareFusion 213, LLC
Recall history in this database
Classification mix: Class II: 29, Class I: 15.
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange recall — FDA D-0643-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
ChloraPrep FREPP, Clear recall — FDA D-0646-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep CLear recall — FDA D-0652-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep CLear recall — FDA D-0651-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Scrub Teal recall — FDA D-0650-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
PURPREP BD PurPrep recall — FDA D-0644-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange recall — FDA D-0647-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Scrub Teal recall — FDA D-0649-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange recall — FDA D-0648-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 8, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Clear recall — FDA D-0645-2026
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 1, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Clear recall — FDA D-0622-2026
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 1, 2026
CHLORAPREP ONE-STEP BD ChloraPrep FREPP Clear recall — FDA D-0623-2026
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class IIFDA: OngoingCareFusion 213, LLC
DrugJul 1, 2026
CHLORAPREP ONE-STEP BD ChloraPrep Clear recall — FDA D-0624-2026
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class IFDA: OngoingCareFusion 213, LLC
DrugJul 1, 2026
CHLORAPREP ONE-STEP BD ChloraPrep FREPP Clear recall — FDA D-0625-2026
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.
Class IFDA: OngoingCareFusion 213, LLC
DrugMay 13, 2026
PURPREP BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol recall — FDA D-0518-2026
Lack of assurance of Sterility: potential product contamination
Class IIFDA: OngoingCareFusion 213, LLC
DrugMay 28, 2025
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0441-2025
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class IIFDA: OngoingCareFusion 213, LLC
DrugMar 19, 2025
CHLORAPREP ONE-STEP BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate recall — FDA D-0259-2025
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class IFDA: OngoingCareFusion 213, LLC
DrugSep 27, 2023
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-1168-2023
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…
Class IIFDA: CompletedCareFusion 213, LLC
DrugMay 19, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange 26 mL Applicator recall — FDA D-0373-2021
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class IFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CareFusion 213 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0345-2021
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…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0343-2021
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…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CareFusion 213 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0350-2021
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…
Class IIFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and recall — FDA D-0344-2021
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…
Class IFDA: TerminatedCareFusion 213, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Carefusion 213, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.