Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-1685-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

Product Classification:

Class II

Date Initiated: March 5, 2020

Date Posted: April 15, 2020

Recall Number: Z-1685-2020

Event ID: 85103

Reason for Recall:

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

Status: Terminated

Product Quantity: 386 units

Code Information:

Product Code 5111-00250-060; GEM2753; Lots SP19J11-1402242; SP19J11-1402246; and SP19J11-1402265

Distribution Pattern:

Worldwide distribution - United States Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI and countries of Saudi Arabia, Italy, Austria, Argentina, Japan, Israel, Spain, South Africa, Greece, Australia, France, Sweden, Netherlands, UK, Germany and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated