FDA Expands Recall of Medline Convenience Kits Over Open Seal on BD ChloraPrep Applicators
The FDA has expanded a recall of Medline convenience kits to include additional codes, citing an open or incomplete seal on BD ChloraPrep Clear 1 mL applicators.
5 reports on this incident · first at Sep 1, 2026, 10:46 p.m. ET
Earlier reports
Sep 1, 2026, 11:53 p.m. ET
FDA Reclassifies Medline Convenience Kit Recall as Class II
The U.S. Food and Drug Administration has reclassified the recall of Medline convenience kits containing BD ChloraPrep Clear 1 mL applicators as Class II, according to an FDA enforcement report published August 31, 2026. The recall, initiated July 20, 2026, covers 222,653 units distributed nationwide. The agency's Class II designation is its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, per the FDA's recall definitions.
The recall was prompted by 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. The FDA recall records reviewed for this report do not report any injuries. The remedy instructs 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 are to be returned. The recall status is open.
The FDA database records no other enforcement action by this firm, according to the agency's enforcement records.
Sep 1, 2026, 11:23 p.m. ET
FDA Reports Injuries in Medline Convenience Kit Recall Over Open Seal on BD ChloraPrep Applicators
The FDA's enforcement report for recall number 99561, dated 2026-08-31, now states that injuries have been reported in connection with the recall of Medline convenience kits containing BD ChloraPrep Clear 1 mL applicators. The agency's record does not specify the number or nature of the injuries, and it does not state that they are linked to the open or incomplete seal that prompted the recall.
The recall, initiated on 2026-07-20, covers 222,653 units distributed nationwide. The FDA classifies it as Class II, its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The hazard listed is localized skin or soft tissue infection, or a systemic infection or infectious complication.
The remedy instructs 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 are to be returned. The FDA's database records no other enforcement action by this firm.
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.
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