Edwards Lifesciences Suction Wand — Class II medical device recall Z-1749-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-07-24, distributed nationwide. Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside th
| Recall number | Z-1749-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-07-17 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility, specification failure |
| Model numbers | S099, S0998B, S099B |
Product
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
Reason for recall
Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
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-1749-2013. 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.