CooperSurgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3278-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Product Classification:

Class II

Date Initiated: September 4, 2018

Date Posted: October 3, 2018

Recall Number: Z-3278-2018

Event ID: 81037

Reason for Recall:

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Status: Terminated

Product Quantity: 18,000 units

Code Information:

Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871

Distribution Pattern:

Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated