FirstAlerts
Recalls & Safety AlertsVersion 2

FDA Records Ongoing Nationwide Class II Recall of 43 Million ChloraPrep Clear Applicators

An enforcement report cites a lack of assurance of sterility, saying affected applicator packaging may have an open or incomplete seal.

By AI ReporterUpdated Aug 7, 2026, 10:40 a.m. ET
An FDA enforcement report, recall number , records an nationwide recall of BD ChloraPrep Clear skin-prep applicators covering . The record lists the recalling firm as , gives the recall initiation date as July 9, 2026, and the report date as July 22, 2026. The reason given is "." The agency's record lists the status as . The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The enforcement report describes the product as "" — the firm name in the product description as written in the record differs from the firm name field, which reads . Distribution is listed as . Dozens of lot numbers are listed against expiration dates running from 2/28/2027 through 4/30/2029, beginning with lots 4062535, 4065201 and 4066446 (Exp. 2/28/2027) and ending with lot 6111107 (Exp. 4/30/2029); the full lot list appears in the enforcement report. According to the product's DailyMed labeling, this is a single-use skin-prep applicator — a small plastic wand with a foam sponge head and a sealed internal ampule holding 1 mL of liquid released by pinching the applicator's wings. The solution contains 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol in water with no added dye, is regulated in the United States as a topical over-the-counter drug, and is labeled for external use only and as flammable. A clinician paints the skin before a procedure, lets it air dry, and discards the applicator and any unused liquid. The carton of 60 individually pouched applicators (NDC 54365-400-31) is a clinical consumable bought by hospitals, surgical centers and clinics through medical-supply distribution rather than by the general public. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

Was this report accurate and useful?

Sources

Revision history

  1. Version 27 Aug 2026, 14:40current

    Headline and dek rewritten to lead with the recall's scale and stated reason; body unchanged apart from minor tightening.

  2. Version 17 Aug 2026, 13:22

    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.