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 Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Recalled by DeRoyal Industries Inc Due to DeRoyal manufactured custom sterile surgical kits containing the...

Date: December 19, 2017
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 Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical

Quantity: 226 kits

Why Was This Recalled?

DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.

Where Was This Sold?

This product was distributed to 2 states: CA, MO

Affected (2 states)Not affected

About DeRoyal Industries Inc

DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.

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