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 Recalled by Edwards Lifesciences, LLC Due to Edwards is recalling certain lots of Rigid Suction...

Date: June 19, 2013
Company: Edwards Lifesciences, LLC
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 Edwards Lifesciences, LLC directly.

Affected Products

Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

Quantity: S099: 171,587 units and S099B: 505,107 units

Why Was This Recalled?

Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edwards Lifesciences, LLC

Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.

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