BD ChloraPrep Clear Preoperative Skin Prep: Open Seal Risk
Recall of BD ChloraPrep Clear 2% CHG and 70% IPA preoperative skin prep due to potential open seal on packaging, risking contamination.
Lower-risk recall
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Contact the company
What happened, in plain English
BD ChloraPrep Clear preoperative skin preparation solution is recalled because the packaging may have an open seal, which could lead to contamination. This affects patients undergoing surgery who use the product. Read more at govinfonow.com/recall/32077-bd-chloraprep-clear-preoperative-skin-prep-open-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32077-bd-chloraprep-clear-preoperative-skin-prep-open-seal-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0441-2025
Cite this page
“BD ChloraPrep Clear Preoperative Skin Prep: Open Seal Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32077-bd-chloraprep-clear-preoperative-skin-prep-open-seal-risk. Based on FDA recall #D-0441-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0441-2025%22&limit=1).
Why it’s dangerous
The product may have an open seal on the packaging, which could allow contamination. This is a lack of assurance of sterility, meaning the solution might not be sterile when used.
Who’s affected
Patients scheduled for surgery who use this preoperative skin prep solution are affected. Those with the specific lot numbers are at risk of contamination if the packaging seal is compromised.
How to tell if you have this one
Check for the product name 'BD ChloraPrep Clear', lot numbers 3354127 or 3350974, and expiration date 12/31/2026 on the packaging.
- Brand
BD- Category
Drug
What to do — step by step
Check Packaging Seal
Inspect the packaging for an open seal; if present, do not use the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the product?
Check the packaging for an open seal; if found, do not use it. Contact BD for further instructions.
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Where this comes from
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.
- Official source: FDA Recall #D-0441-2025 (May 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0441-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.