Harvest Graft Delivery System — Class II medical device recall Z-0022-2014
Terminated recall by Harvest Technologies Corporation, reported 2013-10-23, distributed nationwide. Potential for leur connector to leak or have cracks.
| Recall number | Z-0022-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Harvest Technologies Corporation, Plymouth, MA, United States |
| Recall initiated | 2013-09-11 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2014-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CN, DO, SG, VN |
| Reason classes | packaging |
| Model numbers | GDP-10 |
Product
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Reason for recall
Potential for leur connector to leak or have cracks.
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-0022-2014. 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.