Class II — Potential Health Hazard

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

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI Recalled by DeRoyal Industries Inc Due to The outer package seal could be open, or...

Date: May 30, 2023
Company: DeRoyal Industries Inc
Status: Ongoing
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

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

Quantity: 328 packs

Why Was This Recalled?

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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