OriGen Biomedical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1068-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 19, 2023

Date Posted: February 21, 2024

Recall Number: Z-1068-2024

Event ID: 93752

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.

Status: Ongoing

Product Quantity: 3613 Cases

Code Information:

REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281

Distribution Pattern:

US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE

Voluntary or Mandated:

Voluntary: Firm initiated