CooperSurgical Retractor System Elastic Stays Recall: Infection Risk
CooperSurgical recalls Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) due to possible compromised sterile pouch seals increasing infection risk. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
Lower-risk recall
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Contact the company
What happened, in plain English
CooperSurgical is recalling Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) because the sterile pouch seals might be compromised, increasing infection risk during medical procedures. This affects specific production lots sold to hospitals and surgical centers. Read more at govinfonow.com/recall/69911-coopersurgical-retractor-system-elastic-stays-recall-infection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69911-coopersurgical-retractor-system-elastic-stays-recall-infection-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3278-2018
Cite this page
“CooperSurgical Retractor System Elastic Stays Recall: Infection Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69911-coopersurgical-retractor-system-elastic-stays-recall-infection-risk. Based on FDA recall #Z-3278-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3278-2018%22&limit=1).
Why it’s dangerous
The sterile pouch seals on these medical devices might become compromised, allowing contaminants to enter and increase the risk of infection during surgical procedures. This is a potential issue with the packaging integrity of the single-use device.
Who’s affected
Hospitals and surgical centers that purchased the recalled Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) from specific production lots. Medical staff using these devices during procedures are at risk of infection if the seal is compromised.
How to tell if you have this one
Check for the product name 'Retractor System Elastic Stays' with part numbers 3314-lG, 3316-lG, or 3550-lG. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
- Brand
CooperSurgical- Category
Medical device
What to do — step by step
Check Product Lot Number
Identify the lot number on the device packaging to determine if it is one of the affected lots: 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, or 248871.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 29 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3278-2018 (September 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3278-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.