Class II — Potential Health Hazard

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

Open Heart Pack Recalled by DeRoyal Industries Inc Due to Sternum saw blades within procedure packs are not...

Date: January 25, 2021
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

Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.

Quantity: 1084 packs

Why Was This Recalled?

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Where Was This Sold?

This product was distributed to 3 states: MI, OK, TX

Affected (3 states)Not affected

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