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 Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing Recalled by DeRoyal Industries Inc Due to DeRoyal Industries is recalling their product Insufflation Tubing...

Date: July 15, 2013
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 Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.

Quantity: 506,632 sets in US; 17,854 sets International

Why Was This Recalled?

DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.

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.

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