Lower risk Medical device recall · FDA · Published December 19, 2023

OriGen Accessory Sets Syringes: Yellowed Syringes May Not Be Safe

OriGen recalls 6ml and 60ml syringes with yellowed tubing due to gamma sterilization issues. These syringes may not function safely for medical use. Affected units have specific reference numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1068-2024Medical device OriGen ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOriGen Biomedical, Inc.7000 Burleson Rd Bldg D · Austin, TX 78744-3202

✎ GovInfoNow plain-language explainer

OriGen is recalling 6ml and 60ml syringes that turned yellow after gamma sterilization. This could mean the syringes aren't safe for medical use as they weren't properly qualified for the accessory's intended purpose. Read more at govinfonow.com/recall/56537-origen-accessory-sets-syringes-yellowed-syringes-may-not-be-safe.

Source Summary by GovInfoNow · govinfonow.com/recall/56537-origen-accessory-sets-syringes-yellowed-syringes-may-not-be-safe · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1068-2024

Cite this page

“OriGen Accessory Sets Syringes: Yellowed Syringes May Not Be Safe.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56537-origen-accessory-sets-syringes-yellowed-syringes-may-not-be-safe. Based on FDA recall #Z-1068-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1068-2024%22&limit=1).

The FDA announced on December 19, 2023, that OriGen Biomedical, Inc. is recalling accessory set syringes because they contain syringes not yet qualified for the intended purpose. The firm initiated this voluntary Class II recall due to design changes and material issues affecting gamma sterilization.

How to tell if you have it

Brand: OriGen
Product: Accessory Sets Syringes
6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15
60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
REF/UDI-DI/Lots: RF-T15/10816203020205/V23277, V23278, V23639
REF/UDI-DI/Lots: 15-RF60-T/10816203020571/V23281
Quantity: 3613 Cases

The hazard

The accessory sets contain syringes that were gamma sterilized but resulted in yellowed syringes due to design changes to the syringe barrels and a polypropylene resin change that caused a loss of gamma compatibility. The FDA stated these syringes are not yet qualified for the accessory's intended purpose.

Context

GovInfoNow's records show OriGen Biomedical, Inc. has had five other recalls since August 2, 2017, including an Evolve Cell Culture Bag recall on January 28, 2021, for incorrect phthalate labeling. Other recent recalls of similar products include Medline's February 27, 2026, recall of 10mL Polycarbonate Syringes and Convenience Kits with colored or unapproved syringes due to unapproved design changes.

How to tell if you have this one

Check for yellowed syringes with reference numbers RF-T15 or 15-RF60-T. The syringes have specific lot numbers like V23277, V23278, V23639.

Brand
OriGen
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Yellowing
Look for yellowed syringes with reference numbers RF-T15 or 15-RF60-T.

Where it went and when

Where it was distributed

Distributed in 10 states.

FDA distribution: “US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Maryland, Massachusetts, Nebraska, New Jersey, North Dakota, Ohio, Texas, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

Dec 19, 2023Firm started the recall
Feb 9, 2024FDA classified it Class II
Feb 21, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More OriGen recalls

Link to this recall

<a href="https://govinfonow.com/recall/56537-origen-accessory-sets-syringes-yellowed-syringes-may-not-be-safe">OriGen Accessory Sets Syringes: Yellowed Syringes May Not Be Safe (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1068-2024 (December 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1068-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.