CareFusion 213, LLC

Complete recall history across all FDA and CPSC categories — 31 total recalls

CareFusion 213, LLC appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (30)

FDA drug safety enforcement actions by CareFusion 213, LLC

Date Product Reason Class
Dec 17, 2025 BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... Lack of Assurance of Sterlity Class II
May 15, 2025 BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: The affected product may exhibit an open seal... Class II
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in ... Class I
Aug 25, 2023 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Stability data does not support expiry: Shelf-life of the impacted lots of BD... Class II
Apr 20, 2021 BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... Defective Delivery System: An increase in complaints identified endcap being ... Class I
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... CGMP Deviations: Product is being recalled because at labeled storage condit... Class II
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Product:.Product is being recalled bec... Class I
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: Product is being recalled because at labeled... Class II
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Lack of Assurance of Sterility: Product is being recalled because at labeled... Class II
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility.Product is being recalled because at labeled storage conditions... Class I
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... CGMP Deviations: Product is being recalled because at labeled storage condit... Class II
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility.Product is being recalled because at labeled storage conditions... Class I
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product.Product is being recalled beca... Class I
Jul 7, 2020 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product: Product is being recalled to ... Class I
Jul 7, 2020 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility: Product is being recalled to climatic Zone IV regions of the w... Class I
Jul 7, 2020 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility: Product is being recalled to climatic Zone IV regions of the w... Class I
Jul 7, 2020 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Products:Product is being recalled to ... Class I
Jun 23, 2020 ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penic... Class I
Jun 23, 2020 BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... Non-Sterility: Product is being recalled due to presence of Aspergillus Penic... Class I
Jun 23, 2020 ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penic... Class I
Oct 24, 2014 Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, Car... Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is bei... Class III
Jun 13, 2013 ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr... Lack of Assurance of Sterility; Immediate product pouches may not be properly... Class II
Mar 4, 2013 Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Mar 4, 2013 SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Mar 4, 2013 FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net ... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Mar 4, 2013 SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators ... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Mar 4, 2013 Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 S... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Mar 4, 2013 SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP ... Labeling: Not Elsewhere Classified: This product is misbranded because the pr... Class II
Apr 23, 2012 ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alc... Lack of Assurance of Sterility: Firm mistakenly released quarantined, non con... Class II
Nov 8, 2011 ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative S... Lack of Assurance of Sterility: A customer complaint reported some units had ... Class II

Device Recalls (1)

FDA medical device enforcement actions by CareFusion 213, LLC

Date Product Reason Class
Mar 4, 2013 Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... An internal review of CareFusion's labeling for preoperative skin prep produc... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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