Z-3278-2018Class II

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG)

Name: Z-3278-2018 Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG)
Creator: CooperSurgical, Inc.
Published: 2018-09-04
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2018-09-04 / Terminated / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of 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... on 2018-09-04. FDA classified it as Class II and gives the reason as "There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3278-2018
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Posted: 2018-09-27
Terminated: 2020-04-15
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.
Product code: GAD Retractor
Reason for recall: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3278-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3278-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27

Product code GAD

K791665Class IScotts Surgical Retractor and ElasticLone Star Medical Products, Inc. / cleared 1979-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)