Facility

OriGen Biomedical, Inc.

9 recall(s) on record — most severe on record: Class I.

Key facts

9recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3042484745
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2215 Grand Avenue Pkwy Austin, TX, US 78728
Registration status	Active · expires 2026
Parent company	ORIGEN BIOMEDICAL, INC. (owner-operator 9004483)
Brand names	PermaLife® Cell Culture Bag

Activity by year

Recalls (9)

Devices registered here (1)

Container, Frozen Donor Tissue Storage
Product code LPZ (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2023-12-19
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 resul…
Class IIITerminated2021-01-28
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Class IITerminated2019-06-24
The firm has become aware that they have distributed product that was expired.
Class IITerminated2018-08-21
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Class IITerminated2018-08-21
The catheter failed the endotoxin testing.
Class ITerminated2017-08-02
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
Class ITerminated2017-01-17
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later f…
Class ITerminated2015-03-30
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Class ITerminated2015-03-30
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “OriGen Biomedical, Inc. (FEI 3042484745) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042484745-origen-biomedical-inc/

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