The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0643-2026·Announced 2026-07-08

ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.

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: FDA classified this as Class II, and the hazard involves lack of sterility assurance for a topical drug product intended for use on skin, which presents a significant risk of infection and harm. Class II recalls with risk of serious health consequences meet the Severe threshold.

Plain-English summary

CareFusion 213, LLC is recalling BD ChloraPrep Hi-Lite Orange applicators (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) packaged as 100 x 10.5 mL applicators per case. The recall affects 1,800 units nationwide.

The recalled product was intended for further processing and sterilization before use. However, unsterilized applicators were distributed to customers outside of the intended distribution channel, creating a lack of assurance of sterility.

The recalled lot numbers are: 3362296 (expires 12/31/2026), 4066870 (expires 02/28/2027), 4104107 (expires 03/31/2027), 4276125 (expires 09/30/2027), 4080695 (expires 03/31/2027), and 4233300 (expires 08/31/2027). Customers who have received these products should contact CareFusion 213, LLC for instructions on proper handling and replacement.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical Antiseptic
Hazard
Affected units
1,800

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 (10)

  • Lot: a) 3362296
  • expires: 12/31/2026
  • 4066870
  • expires: 02/28/2027
  • 4104107
  • expires: 03/31/2027
  • 4276125
  • expires: 09/30/2027
  • b) 4080695
  • 4233300 expires: 08/31/2027.

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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