ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall for a topical antiseptic product lacking assurance of sterility. The source text does not report any illnesses or injuries, but unsterilized antiseptic applicators intended for medical use present a significant risk of harm (infection) if used on patients; therefore the score is 4 per the rubric for Class II recalls with risk-of-harm products where injury has not yet been reported.
Plain-English summary
ChloraPrep One-Step (2% chlorhexidine gluconate and 70% isopropyl alcohol) applicators in 3 mL packages are being recalled by CareFusion 213, LLC. The product was manufactured for further processing and sterilization but was instead distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
Approximately 7,650 units have been distributed nationwide. The affected product includes multiple lot numbers with expiration dates ranging from June 2026 through April 2028. Healthcare facilities and providers who have received this product should not use it and should contact CareFusion 213, LLC for instructions on return or disposal.
This is a Class II recall. Customers and healthcare providers should verify the lot numbers of any ChloraPrep One-Step applicators in their possession against the recall list and segregate any affected batches. For questions or to report any use of the recalled product, contact the manufacturer.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 7,650
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot: a) 3194046
- Exp. 06/30/2026
- 3217036
- Exp 07/31/2026
- 3279434
- Exp 09/30/2026
- 3286268
- 3304460
- Exp 10/31/2026
- 3346277
- Exp 11/30/2026
- 4031686
- 4039656
- Exp 01/31/2027
- 4048949
- 4060437
- 4067207
- Exp 02/28/2027
- 4092773
- 4094978
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Same manufacturer · CareFusion 213, LLC
See all →- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- CriticalChloraPrep One-Step Recalled for Fungal Contamination and Package Breach
FDA (Drugs) · 2021-05-05
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach
FDA (Drugs) · 2021-05-05