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Medium risk Medical DevicesClass II

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, 25x26mL Applicators per car

Updated April 22, 2026

BD PurPrep povidone-iodine sterile skin prep solution (25 applicators per carton) may not be sterile due to potential product contamination. Using a non-sterile applicator could introduce infection at injection or surgical sites.

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, 25x26mL applicators per carton. Manufacturer: CareFusion 213 LLC, El Paso, TX 79912. NDC: 54365-014-42.

Am I affected

You're affected if you have this product: BD PurPrep povidone-iodine sterile solution in the 25-applicator carton format with NDC 54365-014-42, manufactured by CareFusion 213 LLC.

What to do right now

Stop using this product immediately. Contact CareFusion 213 LLC or the seller for return instructions and a replacement. Do not use any remaining applicators for skin preparation.

The hazard

Lack of assurance of Sterility: potential product contamination

Brands affected

CareFusion 213, LLC
Source
FDA
Category
Medical Devices
Recall ID
fda-D-0517-2026
Classification
Class II
Recalled
April 22, 2026
Read the official notice

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