Baxter Healthcare Corporation: Medical Device Recall in 2019 - (Recall #: Z-0680-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

GEM Coupler Forceps, GEM4183C, packaged individually.

Product Classification:

Class II

Date Initiated: November 2, 2018

Date Posted: January 2, 2019

Recall Number: Z-0680-2019

Event ID: 81581

Reason for Recall:

Potential presence of rust on Coupler Forceps (GEM4183C).

Status: Ongoing

Product Quantity: 123 devices

Code Information:

Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850

Distribution Pattern:

Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia

Voluntary or Mandated:

Voluntary: Firm initiated