Styker Orthobiologics Vita Plasma Separator — Class II medical device recall Z-0431-2013
Terminated recall by Stryker Orthobiologics, Inc., reported 2012-11-28, distributed nationwide. When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of
| Recall number | Z-0431-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Orthobiologics, Inc., Malvern, PA, United States |
| Recall initiated | 2012-07-26 |
| Classified | 2012-11-22 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,268 |
| Lot numbers | T1203002, T1204005, T1206001 |
| Model numbers | 2113-0013 |
Product
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
Reason for recall
When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
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-0431-2013. 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.