VenaSeal — Class II medical device recall Z-1599-2015
Terminated recall by Covidien LLC, reported 2015-05-20. Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface ste
| Recall number | Z-1599-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, Mansfield, MA, United States |
| Recall initiated | 2015-04-28 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2016-03-29 |
| Countries outside the US | AE, AU, CA, CH, DE, FR, GB, HK, IE, IT, LV, NL, NO, PT |
| Quantity | 1,661 units |
| Reason classes | sterility |
| Lot numbers | 34193, 35585, 35766, 36191, 36192, 36617, 36618, 37007, 37399, 37400, 37621, 37622, 38263, 38286, 38407, 38417, 38756, 38804, 38863, 38864, 39111, 39113, 39123, 39336, 39378, 39469, 39670, 39739, 39848, 39970, 39971, 39972, 39973, 40067, 40069, 40075, 40160, 40187, 40243, 40271 and 1 more |
| Model numbers | 34193, 35585, 35766, 36191, 36192, 36617, 36618, 37007, 37399, 37400, 37621, 37622, 38263, 38286, 38407, 38417, 38756, 38804, 38863, 38864, 39111, 39113, 39123, 39336, 39378 and 19 more |
Product
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Reason for recall
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
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-1599-2015. 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.