CareFusion 213, LLC
Complete recall history across all FDA and CPSC categories — 31 total recalls
Recall Summary
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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