Class II — Potential Health Hazard

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

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP) Recalled by Stryker Corporation Due to The heated tube sets were consistently leaking and...

Date: March 7, 2019
Company: Stryker Corporation
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 Stryker Corporation directly.

Affected Products

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Quantity: 5,089 boxes

Why Was This Recalled?

The heated tube sets were consistently leaking and detaching from the cassette.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Corporation

Stryker Corporation has 108 total recalls tracked by RecallDetector.

Related Recalls

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