Edwards Lifesciences, LLC: Medical Device Recall in 2021 - (Recall #: Z-2281-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

Product Classification:

Class II

Date Initiated: July 9, 2021

Date Posted: August 18, 2021

Recall Number: Z-2281-2021

Event ID: 88270

Reason for Recall:

There is a potential for internal leaks within catheters.

Status: Terminated

Product Quantity: 178 units

Code Information:

Lot numbers: 62685542, 62685542, 63316354, 62685542, 62704123, 62685542, 62685542, 62667413, 62685542, 62704123, 62685542, 63608316, 62685542, 62704123, 62685542, 62685542, 62704123, 62685542, 62685542

Distribution Pattern:

US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada

Voluntary or Mandated:

Voluntary: Firm initiated