Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accessory Sets Syringes: 6ml syringe with a female luer with Recalled by OriGen Biomedical, Inc. Due to Accessory sets contain a syringes not yet qualified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.
Affected Products
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
Quantity: 3613 Cases
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 11 states: CA, DE, FL, MD, MA, NE, NJ, ND, OH, TX, WA
About OriGen Biomedical, Inc.
OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report