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OriGen Biomedical Inc.

United States Last updated 25 Oct 2026

Devices
296
Registries
EUDAMEDGUDIDFDA
FDA recalls
201 ongoing

Catalogue296

Page 5 of 6

Showing 201-250 of 296

FDA recalls20

Device pages show only the recalls that name the device or its 510(k)/PMA.

Showing the 10 most recent of 20 recalls.

  • 2023

    • 19 Dec 2023 Z-1068-2024 Class II Ongoing 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.via FDA establishment OriGen Biomedical, Inc.

  • 2021

    • 28 Jan 2021 Z-1409-2021 Class III Terminated It was identified that tissue culture bags were incorrectly labeled as free of phthalates.via FDA establishment OriGen Biomedical, Inc.

  • 2019

    • 24 Jun 2019 Z-0318-2021 Class II Terminated The firm has become aware that they have distributed product that was expired.via FDA establishment OriGen Biomedical, Inc.

  • 2018

    • 21 Aug 2018 Z-0102-2019 Class II Terminated The catheter failed the endotoxin testing.via FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0179-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0180-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0181-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0182-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0183-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
    • 21 Aug 2018 Z-0184-2019 Class II Terminated 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 tipvia FDA establishment OriGen Biomedical, Inc.
Show all 20 recalls

  • 2017

    • 2 Aug 2017 Z-0021-2018 Class I Terminated 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).via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1227-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1228-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1229-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1230-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1231-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.
    • 17 Jan 2017 Z-1232-2019 Class I Terminated 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 fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.via FDA establishment OriGen Biomedical, Inc.

  • 2015

    • 30 Mar 2015 Z-0269-2019 Class I Terminated Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damagevia FDA establishment OriGen Biomedical, Inc.
    • 30 Mar 2015 Z-1456-2015 Class I Terminated 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.via FDA establishment OriGen Biomedical, Inc.

  • 2002

    • 16 Dec 2002 Z-0055-06 Unclassified (pre-2012) Terminated Leak between two lumens causes reduced performance.via FDA establishment OriGen Biomedical, Inc.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • OriGen Biomedical, Inc. Austin, TX · US FEI 1000160256

About

OriGen Biomedical manufactures cryo bags for cryopreservation of blood components, cell culture bags, dimethylsulfoxide, and respiratory products.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does OriGen Biomedical Inc. have in the registry?

The registry currently lists 296 devices for OriGen Biomedical Inc.. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for OriGen Biomedical Inc.?

FDA recall records list 20 recalls initiated by OriGen Biomedical Inc., the most recent initiated on 2023-12-19. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

Which FDA establishments are linked to OriGen Biomedical Inc.?

1 FDA establishment is linked to OriGen Biomedical Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
2215, Grand Avenue Parkway, Austin, United States
Phone
+1 512-474-7278
PRRC contact
Sam Saleh
EUDAMED SRN
US-MF-000018098
FDA FEI number
3042484745
DUNS number
625272232