Class II — Potential Health Hazard

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

Edwards Lifesciences Suction Wand Model S099B Recalled by Sorin Group USA, Inc. Due to Sorin Group is recalling certain lots of Edwards...

Date: July 8, 2013
Company: Sorin Group USA, 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 Sorin Group USA, Inc. directly.

Affected Products

Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

Quantity: 18,927 packs

Why Was This Recalled?

Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sorin Group USA, Inc.

Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.

Related Recalls

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