Edwards Lifesciences Suction Wand Model S099B — Class II medical device recall Z-1985-2013
Terminated recall by Sorin Group USA, Inc., reported 2013-08-28, distributed nationwide. Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plas
| Recall number | Z-1985-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2013-07-08 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 18,927 packages |
| Model numbers | 099B |
Product
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Reason for recall
Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
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-1985-2013. 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.