FDA recall, , High risk
BD ChloraPrep Clear Applicators
BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.
Summary by Recall Canary from the FDA notice
What happened
BD (Becton, Dickinson and Company) is voluntarily recalling ChloraPrep Clear 1 mL Applicator and FREPP Clear 1.5 mL Applicator with paper lidding to the consumer level. The products are being recalled due to fungal contami and lack of assurance of sterility due to wrinkles in the paper lidding which may breach the seal area. The recall was announced on June 6, 2026, and distribution was nationwide in the USA, as well as other foreign distribution.
What to do
If a code on your package is listed below:
- Customers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.
- Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s North American Regional Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 8a.m. and 5 p.m. CT or by emailing: productcomplaints@
bd.com.
Is yours affected?
Compare every listed detail under your product with its label.
An NDC (National Drug Code) is usually printed on the drug's label.
BD ChloraPrep™ Clear - 1 mL Applicators
- NDC
- 54365-400-31
- Catalog (ref) number
- 930480
- Lot code
- 4032183
- Best-by or expiration date
- 01/31/2027
BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators
- NDC
- 54365-400-30
- Catalog (ref) number
- 930299
- Lot code
- 4073005
- Best-by or expiration date
- 03/31/2027
Recall details
- Company began the recall
- Sold in
Nationwide inthe USA, as well as other foreign distribution.
- Company
- CareFusion 213, LLCEl Paso, Texas
- Hazard
- Sterility problem
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99114
- Recall numbers
- D-0622-2026 to D-0625-2026
All recalls from CareFusion 213, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Summary updated
