The Steripath Gen2 Blood Collection System Model Number/Description… — Class II medical device recall Z-0318-2022
Terminated recall by Magnolia Medical Technologies, Inc., reported 2021-12-08, distributed nationwide. Due to an uptick of complaints associated with premature needle retraction of blood collection system.
| Recall number | Z-0318-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magnolia Medical Technologies, Inc., Seattle, WA, United States |
| Recall initiated | 2021-11-02 |
| Classified | 2021-12-01 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2023-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 137,200 devices |
| UPC / GTIN / UDI-DI | 00858366007016, 00858366007023, 00858366007030, 00858366007047, 10858366007013, 10858366007020, 10858366007037, 10858366007044 |
| Lot numbers | 5005328, 5005432, 9446547, 9446696, 9446708, 9446807, 9446903, 9446991, 9446994, 9447043, 9447120, 9447121, 9447122, 9447124, 9447412, 9447413, GEN2 |
Product
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
Reason for recall
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
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-0318-2022. 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.