FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: 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.
- Recall number
- Z-3278-2018
- Recalling firm
- CooperSurgical, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-09-04
- Posted
- not on file
- Terminated
- 2020-04-15
- Reason
- There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
- Root cause
- Nonconforming Material/Component
- Action
- Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers to do the following: Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you have no affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.
- Quantity
- 18,000 units
- Distribution
- 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.
- Lot, serial or model codes
- Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
- 510(k) numbers
- ["K791665"]
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28