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The FDA classified as Class I a recall involving certain Medline convenience kits containing two specified lots of BD ChloraPrep applicators. Medline advised affected customers to quarantine and destroy the entire kit after completing response forms, rather than remove only the applicator. As of August 17, Medline had reported no serious injuries or deaths associated with the issue.
The FDA on October 13, 2026, classified as a Class I recall Medline convenience kits containing two specified lots of BD ChloraPrep applicators, the agency’s most serious recall category. Medline has told affected customers to quarantine and destroy the entire kit, because the applicators may be contaminated with a fungus that can cause severe infection.
The affected products contain one of two applicators: ChloraPrep Clear 1 mL Single Sterile, item 930480, lot 4032183; or FREPP Clear 1.5 mL with paper lidding, item 930299, lot 4073005. The FDA says the action applies to certain Medline convenience kits containing those specific products and lots, not every Medline kit or every ChloraPrep applicator.
Medline’s August 11 letter instructed customers to check inventory, quarantine affected kits, complete response forms and then destroy the entire kit. Distributors and others who resold or transferred the products were asked to notify recipients and request that they destroy affected kits, recording customers’ quantities on the response form.
The updated instructions replace earlier directions for the listed products. A June 12 Medline notification had told customers to place an over-label on affected kits and remove and discard the applicator at the point of use. The FDA says the revised whole-kit destruction instruction applies only to the items in the current communication; it does not change actions for other kits covered by the June notice.
Why Whole-Kit Destruction Is Required
The recall matters because the products are intended for use in clinical procedures, and the updated directions require facilities to remove the whole convenience kit from inventory rather than rely on discarding only the applicator. Kits may contain instruments, dressings, other materials and pharmaceutical components used during procedures, so the change can affect stock and preparation workflows at health care facilities and distributors.
The FDA says contamination with Aspergillus penicillioides may lead to serious consequences, including systemic infection, sepsis, illness or death. If the fungus enters a patient’s bloodstream during placement of an intravascular catheter, the catheter may need to be removed through an additional procedure. Infection at a surgical site could require medical or surgical intervention and long-term antifungal treatment. These are potential harms described by the agency, not reported outcomes tied to this recall.
For facilities, following the specific lot and item-number information is central to identifying affected stock. The FDA’s notice does not direct customers to discard unrelated kits, including other products covered by the June communication whose instructions were not changed.
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How the Recall Instructions Changed
The issue began with BD’s recall of specified ChloraPrep applicator lots. Medline then notified customers on June 12, 2026, about convenience kits containing affected applicators and initially instructed users to label kits so the applicator could be removed and discarded before use.
After receiving additional recall details from BD, or Becton, Dickinson and Company, Medline sent an updated customer letter on August 11. It said that for the products listed in that communication, potential contamination warranted destroying the entire kit. The FDA issued an Early Alert on August 24 and updated its public communication on October 13 to identify the matter as a Class I recall.
The FDA describes Class I as the most serious type of recall: a situation in which use of, or exposure to, a device may cause serious adverse health consequences or death. The classification describes the risk category; it does not establish that patients have been harmed.
“This device may cause serious injury or death if you continue to use it.”
— FDA recall communication
What Is Not Yet Reported
The FDA notice identifies the affected applicator item numbers and lots but does not provide a count of kits or facilities involved. It also does not say how many kits had been located, quarantined or destroyed by the time of the October 13 update.
Medline had reported no serious injuries or deaths as of August 17, according to the FDA. The notice does not give a later adverse-event total or say whether any non-serious reactions were reported. The agency attributes the risk to fungal contamination that may occur under certain environmental conditions; the notice does not describe the conditions or quantify the likelihood of contamination in an individual kit.
The FDA says the product actions listed in the notice have not changed. Customers should check the full affected-product information and their own inventory rather than assume every kit containing a ChloraPrep product is included.
Steps for Affected Customers
Health care facilities and distributors should review inventory for the two listed item-and-lot combinations, quarantine affected kits, complete the response forms and destroy the kits as directed. Businesses that transferred or resold affected products should contact recipients and request destruction, then include those customers’ quantities on their response forms.
U.S. customers with questions, adverse reactions or quality concerns can contact Medline at 866-359-1704 or recalls@medline.com. Health care professionals and consumers may also report adverse reactions or product-quality problems through the FDA’s MedWatch program. The FDA’s notice does not give a deadline for completing the response or announce a further update date.
Key Questions
Which Medline convenience kits are affected?
The notice identifies kits containing ChloraPrep Clear 1 mL Single Sterile, item 930480, lot 4032183, or FREPP Clear 1.5 mL with paper lidding, item 930299, lot 4073005. Check the product and lot details against the FDA notice and Medline communication.
What should customers do with affected kits?
Medline instructed customers to check stock, quarantine affected kits, complete the response form and then destroy the entire kit. Distributors and resellers should notify recipients and request destruction.
Why must the entire kit be destroyed?
Medline changed its earlier instructions after receiving additional recall details from BD. For the listed products, the revised direction is to destroy the entire kit because of potential fungal contamination, rather than remove only the applicator before use.
Have injuries or deaths been reported?
The FDA says Medline had reported no serious injuries or deaths as of August 17, 2026. The notice does not provide a later adverse-event count.
How can customers contact Medline or report a problem?
U.S. customers can contact Medline at 866-359-1704 or recalls@medline.com. Adverse reactions or quality problems may also be reported through the FDA’s MedWatch program.
Source: primary
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