The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0648-2026·Announced 2026-07-08

ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance

CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.

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 involving a sterile drug product with a critical quality defect (lack of sterility assurance). Unsterilized applicators intended for topical use on skin present a significant risk of infection and contamination, meeting the criteria for Severe classification.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v) sterile solution applicators distributed nationwide. The applicators affected include lot numbers 3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, and 5084224 in 26 mL single-use formats.

The recall was initiated because unsterilized ChloraPrep applicators, which were intended for further processing and sterilization before use, were instead distributed to customers outside of the intended distribution channel. This distribution error creates a lack of assurance regarding product sterility.

Customers who have received affected units should stop using them and contact CareFusion 213, LLC for instructions on return or disposal. Healthcare facilities and customers should verify lot numbers and expiration dates against the recalled lots listed in this notice.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical Antiseptic / Pre-operative Skin Preparation
Hazard
Affected units
400

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 (13)

  • Lot: a) 3291614
  • Exp 10/31/2026
  • 4034080
  • 4036599
  • Exp 01/31/2027
  • 4081350
  • Exp 03/31/2027
  • 5008234
  • Exp 12/31/2027. b) 2320053
  • Exp 11/30/2025
  • 4151258
  • Exp 05/31/2027. 5084224
  • Exp 03/31/2028.

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

Same manufacturer · CareFusion 213, LLC

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Same hazard · lack of sterility

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