CLASS II Device recall · Reported 24 Jul 2013 · FDA Enforcement Report

Suction Wand recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Edwards Lifesciences Suction Wand, distributed nationwide in the US. The recall was initiated on 19 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModels S099 and S099B

Quantity recalledS099: 171,587 units and S099B: 505,107 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1749-2013
FDA event ID: 65492
Recalling firm: Edwards Lifesciences, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2013
FDA classified: 17 Jul 2013
Reported: 24 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

19 Jun 2013	Recall initiated by company
17 Jul 2013	Classified by FDA	+28 days
24 Jul 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Canada.

Nationwide

Questions about this recall

Is Suction Wand recalled?

Yes. Edwards Lifesciences recalled Suction Wand on 19 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1749-2013.

Why was it 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.

Which lots are affected?

Models S099 and S099B

Where was it sold?

Worldwide Distribution - USA (nationwide) and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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