CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
Retractor System Elastic Stays (Part 3314-lG recalled by CooperSurgical
CooperSurgical is recalling Retractor System Elastic Stays (Part 3314-lG, distributed nationwide in the US. The recall was initiated on 4 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3278-2018
- FDA event ID
- 81037
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 27 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 27 Sep 2018 | Classified by FDA | +23 days |
| 3 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Is Retractor System Elastic Stays (Part 3314-lG recalled?
Yes. CooperSurgical recalled Retractor System Elastic Stays (Part 3314-lG on 4 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-3278-2018.
Why was it recalled?
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Which lots are affected?
Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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