Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1749-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 19, 2013

Date Posted: July 24, 2013

Recall Number: Z-1749-2013

Event ID: 65492

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.

Status: Terminated

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

Code Information:

Models S099 and S099B

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated