FDA Reports Injuries in Medline Convenience Kit Recall Over Open Seal on BD ChloraPrep Applicators
The agency's recall record now lists injuries, though it does not specify how many or connect them to the defect.
3 reports on this incident · first at Sep 1, 2026, 10:46 p.m. ET
Earlier reports
Sep 1, 2026, 10:52 p.m. ET
FDA Closes Recall of Medline Convenience Kits Over Open Seal on BD ChloraPrep Applicators
The U.S. Food and Drug Administration has closed the recall of Medline convenience kits containing BD ChloraPrep Clear 1 mL applicators, according to the agency's enforcement report. The closure means the FDA considers the recall carried out.
The recall, initiated July 20, 2026, was classified as Class II, the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The reason for the action was an open or incomplete seal on the applicators, which could lead to localized skin or soft tissue infection, or a systemic infection or infectious complication, as reported by Medical Daily.
The FDA enforcement report, recall number 99561, lists 222,653 units distributed nationwide. The remedy instructed customers to request stickers to over-label affected kits with an instruction to remove the affected applicator and replace it from separate supply; no kits were to be returned. The FDA recall records reviewed for this report do not report any injuries.
The agency's database records no other enforcement action by this firm. The recall status is now closed, according to the enforcement report.
Sep 1, 2026, 10:46 p.m. ETFirst report
Medline Recalls Convenience Kits Over Open Seal on BD ChloraPrep Applicators
Medline has initiated a nationwide recall of convenience kits containing BD ChloraPrep Clear 1 mL applicators, according to a report from Medical Daily. The recall, initiated on July 20, 2026, and reported on August 31, 2026, affects 222,653 units. The reason for the recall is an open or incomplete seal on the applicator, which could lead to localized skin or soft tissue infection, or a systemic infection or infectious complication. The FDA recall records reviewed for this report do not report any injuries.
The FDA has classified this as a Class II recall, the agency's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall number is 99561. The status of the recall is open.
Customers are instructed to request stickers to over-label affected kits with an instruction telling staff to remove the affected applicator and replace it from separate supply. No kits are to be returned. The FDA enforcement report lists Medline as the firm, and the database records no other enforcement action by this firm.
Was this report accurate and useful?
Sources
Revision history
- Version 12 Sept 2026, 02:46current
First published.
- Version 12 Sept 2026, 03:23current
First published.
- Version 12 Sept 2026, 02:52current
First published.
How we work
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.