Retractor System Elastic Stays — Class II medical device recall Z-3278-2018
Terminated recall by CooperSurgical, Inc., reported 2018-10-03, distributed nationwide. There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of i
| Recall number | Z-3278-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2018-09-04 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CO, CZ, DE, ES, GB, IE, IL, IT, LB, NL, SA, SG, TR |
| Quantity | 18,000 units |
| Reason classes | sterility, packaging |
| Lot numbers | 244660, 244667, 244883, 244884, 245603, 245964, 245973, 246138, 248871, 250426, 251395 |
| Model numbers | 3314-LG |
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.
Reason for recall
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3278-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.