Accessory Sets Syringes: 6ml syringe with a female luer with 15cm… — Class II medical device recall Z-1068-2024
Ongoing recall by OriGen Biomedical, Inc., reported 2024-02-21, distributed in CA, FL, MA, MD, ND, NE, NJ, OH…. Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design change
| Recall number | Z-1068-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OriGen Biomedical, Inc., Austin, TX, United States |
| Recall initiated | 2023-12-19 |
| Classified | 2024-02-09 |
| Reported by FDA | 2024-02-21 |
| Distributed | CA, FL, MA, MD, ND, NE, NJ, OH, TX, WA |
| Quantity | 3,613 cases |
| UPC / GTIN / UDI-DI | 10816203020205, 10816203020571 |
| Lot numbers | RF-T15/10816203020205, V23277, V23278, V23639 |
| Model numbers | 15-RF60-T, RF-T15 |
Product
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
Reason for recall
Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
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-1068-2024. 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.