BD recalls ChloraPrep Hi-Lite Orange applicators that may not be sterile, risking infection. Affected lots from 2023-2027 need replacement.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
BD is recalling ChloraPrep Hi-Lite Orange antiseptic applicators because some were distributed without proper sterilization. Using unsterilized items could lead to infections during medical procedures.
The applicators were intended for sterilization but were distributed outside the proper channel. This means they might not be sterile when used, increasing infection risk during medical procedures.
Healthcare professionals using these applicators for medical procedures are most at risk. Patients receiving treatments with unsterilized items could face infection.
Check for BD ChloraPrep Hi-Lite Orange applicators with NDC 54365-400-35 or Catalog Number 930715NS. Lots include 3362296 (expires 12/31/2026), 4066870 (expires 02/28/2027), 4104107 (expires 03/31/2027), and 4276125 (expires 09/30/2027).
Look for lot numbers on the applicator packaging: 3362296, 4066870, 4104107, or 4276125.
If you have the recalled lots, replace with sterile applicators from a reliable source.
No, the recalled applicators were distributed without proper sterilization, so they may not be sterile and could cause infections.
Check the lot number on your applicators. If it matches the recalled lots, replace them with sterile alternatives.
Look for NDC 54365-400-35 or Catalog Number 930715NS on the packaging. Check the lot number against the listed numbers: 3362296, 4066870, 4104107, or 4276125.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall D-0643-2026 — BD BD Hello, I own a BD that is covered by recall D-0643-2026 from BD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
