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# BD Recalls 30 Lots of ChloraPrep Hi-Lite Orange Applicator
- URL: https://www.fdaweb.com/bd-recalls-30-lots-of-chloraprep-hi-lite-orange-applicator/
- Published: 2021-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:55:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149165

FDA says that Becton, Dickinson and Company (BD) is recalling 30 specified lots of its ChloraPrep Hi-Lite Orange 26mL applicator (2% w/w chlorhexidine gluconate and 70% v/v isopropyl alcohol) in the U.S. and U.S. territories. An agency [announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-recall-specified-lots-chlorapreptm-hi-lite-orangetm-26-ml-applicator-united?ref=fdaweb.com) says the product is used as an antiseptic for preparing a patient’s skin before surgery to help reduce bacteria that potentially can cause skin infection. The recall is due to a defective applicator, FDA and the company say.

The notice says the applicator contains glass ampules that house the sterile ChloraPrep solution. In normal circumstances, it says, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge head for application to the patient’s skin.

In certain lots, it says, the applicator end cap was improperly secured due to a manufacturing error. That can result in broken glass and solution dropping out of the applicator once activated. In some cases, according to the notice, the glass ampules can drop out before activation and shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and healthcare professionals.

BD says it has received 56 complaints with one laceration issue reported.