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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, 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

CareFusion 213, LLC
Source
FDA
Category
Medical Devices
Recall ID
fda-D-0518-2026
Classification
Class II
Recalled
April 22, 2026
Read the official notice

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