The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0646-2026·Announced 2026-07-08

ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.

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 distributed without the required sterilization assurance. The hazard—use of unsterilized topical applicators intended for direct patient contact—creates risk of serious adverse health consequences including infection, even though no reported illnesses are stated in the source.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide in the USA. The applicators were intended for further processing and sterilization before use, but unsterilized units were instead distributed to customers outside the intended distribution channel.

The affected product is ChloraPrep FREPP, Clear, 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, supplied as 500 x 1.5 mL applicators per case. The recall affects approximately 10,500 units across multiple lots with expiration dates ranging from September 2026 through April 2028.

Customers who received these applicators should stop using them immediately and contact CareFusion 213, LLC for instructions on return or destruction. Healthcare facilities and medical professionals should verify that ChloraPrep One-Step applicators have been properly sterilized before use in any patient care setting.

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
10,500

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: 3279063
  • Exp. 9/30/2026
  • 3319524
  • 3324094
  • 3343541
  • Exp. 11/30/2026
  • 3357638
  • 4010202
  • Exp. 12/31/2026
  • 4206771
  • Exp. 7/31/2027
  • 4267824
  • 4270191
  • 4282285
  • Exp.9/30/2027
  • 4338352
  • Exp. 11/30/2027
  • 5053657
  • Exp. 2/29/2028
  • 5121340

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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