BD PurPrep Povidone-Iodine Recall
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25
Updated April 22, 2026
BD PurPrep povidone-iodine sterile solution applicators (10.5 mL, 25-pack) are being recalled because the manufacturer cannot confirm they are properly sterilized and free of contamination. Use of a non-sterile product on skin or wounds could introduce infection.
Is the CareFusion 213, LLC recalled? Yes. This product was recalled by FDA on April 22, 2026. Details below.
What is recalled
BD PurPrep Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) applicators, 25 per box. NDC 54365-014-41. Manufactured by CareFusion 213, LLC, El Paso, TX.
Am I affected
You're affected if you have BD PurPrep sterile solution applicators (10.5 mL, 25-pack) with NDC number 54365-014-41 on the box.
What to do right now
Stop using this product. Contact CareFusion 213, LLC or the seller for instructions on how to return or replace affected applicators.
The hazard
Lack of assurance of Sterility: potential product contamination
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-D-0518-2026
- Classification
- Class II
- Recalled
- April 22, 2026
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