Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DeRoyal DEXMED ACCESS CENTER TRAY Recalled by DeRoyal Industries Inc Due to A kit component, the PDI Prevantics Swab was...

Date: March 3, 2022
Company: DeRoyal Industries Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.

Affected Products

DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

Quantity: 1360 kits

Why Was This Recalled?

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Where Was This Sold?

US distribution to Florida, New Jersey, and Tennessee

About DeRoyal Industries Inc

DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report