--- title: "CareFusion 213, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search CareFusion 213, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/carefusion-213-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # CareFusion 213, LLC recall records **20** reported ongoing 21 records in this archive. Latest source date Jul 9, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 9, 2026 FDA drug enforcement ### [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) each, STERILE SOLUTION, CareFusion 123,...](https://isitonrecall.com/recall/fda-drug-d-0690-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-60-x-1-ml-applica/) Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator Class II Reported ongoing Distribution: U.S.A. Nationwide [Official source for BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0690-2026%22) Jun 11, 2026 FDA drug enforcement ### [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 applicators/case, NDC 54365-400-35, Catalo...](https://isitonrecall.com/recall/fda-drug-d-0643-2026-bd-chloraprep-hi-lite-orange-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-pack/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0643-2026%22) Jun 11, 2026 FDA drug enforcement ### [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 SOLUTION, CAREFUSION 213, LLC, EL PASO, TX ...](https://isitonrecall.com/recall/fda-drug-d-0644-2026-bd-purprep-povidone-iodine-8-3-w-w-0-83-available-iodine-with-isopropyl-alcohol-72-5-w-w-50-x-26-ml/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w),...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0644-2026%22) Jun 11, 2026 FDA drug enforcement ### [BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b...](https://isitonrecall.com/recall/fda-drug-d-0645-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-packaged-as-a/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0645-2026%22) Jun 11, 2026 FDA drug enforcement ### [ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, ...](https://isitonrecall.com/recall/fda-drug-d-0646-2026-chloraprep-frepp-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-500-x-1-5-ml-a/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0646-2026%22) Jun 11, 2026 FDA drug enforcement ### [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/case, NDC 54365-400-33, calatog 930415NS...](https://isitonrecall.com/recall/fda-drug-d-0647-2026-bd-chloraprep-hi-lite-orange-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-packaged/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0647-2026%22) Jun 11, 2026 FDA drug enforcement ### [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/case, NDC 54365-400-38, calatog number ...](https://isitonrecall.com/recall/fda-drug-d-0648-2026-bd-chloraprep-hi-lite-orange-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-packaged/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0648-2026%22) Jun 11, 2026 FDA drug enforcement ### [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/case, NDC 54365-400-36, catalog number 93...](https://isitonrecall.com/recall/fda-drug-d-0649-2026-bd-chloraprep-scrub-teal-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-packaged-as/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) pa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0649-2026%22) Jun 11, 2026 FDA drug enforcement ### [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, NDC 54365-400-39, catalog number 93082...](https://isitonrecall.com/recall/fda-drug-d-0650-2026-bd-chloraprep-scrub-teal-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-packaged-as/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) pa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0650-2026%22) Jun 11, 2026 FDA drug enforcement ### [BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsid...](https://isitonrecall.com/recall/fda-drug-d-0651-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-500-x-1-ml-applic/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0651-2026%22) Jun 11, 2026 FDA drug enforcement ### [BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, sub...](https://isitonrecall.com/recall/fda-drug-d-0652-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-100-x-10-5-ml-app/) 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 Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0652-2026%22) May 28, 2026 FDA drug enforcement ### [BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, ...](https://isitonrecall.com/recall/fda-drug-d-0622-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-1-ml-applicat/) Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. Class II Reported ongoing Distribution: Nationwide inthe USA, as well as other foreign distribution. [Official source for BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0622-2026%22) May 28, 2026 FDA drug enforcement ### [BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, E...](https://isitonrecall.com/recall/fda-drug-d-0623-2026-bd-chloraprep-frepp-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-1-5-ml/) Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. Class II Reported ongoing Distribution: Nationwide inthe USA, as well as other foreign distribution. [Official source for BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0623-2026%22) May 28, 2026 FDA drug enforcement ### [BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 2...](https://isitonrecall.com/recall/fda-drug-d-0624-2026-bd-chloraprep-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-1-ml-applicat/) Non-Sterility: Due to presence of Aspergillus penicillioides. Class I Reported ongoing Distribution: Nationwide inthe USA, as well as other foreign distribution. [Official source for BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0624-2026%22) May 28, 2026 FDA drug enforcement ### [BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, E...](https://isitonrecall.com/recall/fda-drug-d-0625-2026-bd-chloraprep-frepp-clear-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-1-5-ml/) 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 I Reported ongoing Distribution: Nationwide inthe USA, as well as other foreign distribution. [Official source for BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IP...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0625-2026%22) Apr 22, 2026 FDA drug enforcement ### [BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX ...](https://isitonrecall.com/recall/fda-drug-d-0517-2026-bd-purprep-povidone-iodine-8-3-w-w-0-83-available-iodine-with-isopropyl-alcohol-72-5-w-w-sterile-sol/) Lack of assurance of Sterility: potential product contamination Class II Reported ongoing Distribution: Nationwide in the USA [Official source for BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w St...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0517-2026%22) Apr 22, 2026 FDA drug enforcement ### [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 25 applicators per box. Carefusion 213,...](https://isitonrecall.com/recall/fda-drug-d-0518-2026-bd-purprep-povidone-iodine-8-3-w-w-0-83-available-iodine-with-isopropyl-alcohol-72-5-w-w-sterile-sol/) Lack of assurance of Sterility: potential product contamination Class II Reported ongoing Distribution: Nationwide in the USA [Official source for BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w St...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0518-2026%22) Dec 17, 2025 FDA drug enforcement ### [BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54...](https://isitonrecall.com/recall/fda-drug-d-0243-2026-bd-chloraprep-triple-swabsticks-chlorhexidine-gluconate-chg-2-w-v-and-isopropyl-alcohol-ipa-70-v-v-5/) Lack of Assurance of Sterlity Class II Reported ongoing Distribution: Nationwide within the United States [Official source for BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IP...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0243-2026%22) May 15, 2025 FDA drug enforcement ### [BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if ...](https://isitonrecall.com/recall/fda-drug-d-0441-2025-bd-chloraprep-clear-2-x-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-ipa-patient-preop/) Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. Class II Reported ongoing Distribution: Nationwide in the U.S. [Official source for BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Pa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0441-2025%22) Feb 14, 2025 FDA drug enforcement ### [BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. ...](https://isitonrecall.com/recall/fda-drug-d-0259-2025-bd-chloraprep-clear-1ml-applicators-2-w-v-chlorhexidine-gluconate-chg-and-70-v-v-isopropyl-alcohol-i/) Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I Reported ongoing Distribution: Nationwide and Canada [Official source for BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl a...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0259-2025%22) ## Reasons in these listed records - Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - 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 - Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - Non-Sterility: Due to presence of Aspergillus penicillioides. These examples come from this result page and are not a ranking of every recall reason. ## Checking CareFusion 213, LLC ### Is there a recall on carefusion 213, llc right now? This archive contains 21 records, including 20 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search CareFusion 213, LLC](https://isitonrecall.com/check/?q=CareFusion%20213%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)