Baxter Healthcare Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code 5111-00250-060, GEM2753, Lots SP19J11-1402242, SP19J11-1402246, and SP19J11-1402265
Products Sold
Product Code 5111-00250-060; GEM2753; Lots SP19J11-1402242; SP19J11-1402246; and SP19J11-1402265
Baxter Healthcare Corporation is recalling GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastom due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
An Urgent Product Recall communication was sent 3/5/2020 to affected customers via USPS First Class Mail. The recalling firm is asking that customer locate and remove all affected product from your facility, Contact Synovis MCA to arrange for return and replacement of the product, and complete the Baxter Customer Reply Form and return it to Baxter by fax or email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026