The Recall Desk

Manufacturer

OriGen Biomedical, Inc.

19 recalls in our database name OriGen Biomedical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
1
Severe
5
Most recent
2024-02-21

Of the 19 recalls from OriGen Biomedical, Inc. we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (26%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • HighFDA (Devices)·Z-1068-2024·2024-02-21

    OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility

    OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.

    Product
    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
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1409-2021·2021-04-21

    OriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling

    OriGen Biomedical is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates.

    Product
    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0318-2021·2020-11-11

    OriGen Biomedical Recalls Expired 3/8 FloPump Medical Devices

    OriGen Biomedical is recalling six units of 3/8-inch FloPump devices distributed in Texas because the products were expired.

    Product
    3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1231-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk

    OriGen Biomedical is recalling 61 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
    Category
    Medical Device
    Distribution
    33 states
  • SevereFDA (Devices)·Z-1229-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect

    OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub if clamped improperly.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1227-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk

    OriGen Biomedical is recalling 260 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1228-2019·2019-06-12

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Bond Failure

    OriGen Biomedical is recalling 72 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.

    Product
    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
    Category
    Medical Device
    Distribution
    33 states
  • CriticalFDA (Devices)·Z-0269-2019·2018-11-14

    OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation

    OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 435 Reinforced Dual Lumen Cannulas because they may lack barium sulfate and have tips shorter than labeled.

    Product
    Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2019·2018-10-24

    OriGen Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 73 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Endotoxin Failure

    OriGen Biomedical is recalling 106 units of Reinforced Dual Lumen Cannulas because they failed endotoxin testing. The devices were distributed in 25 US states and four foreign countries.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2019·2018-10-24

    OriGen Biomedical Recalls 13Fr Reinforced Dual Lumen Cannulas

    OriGen Biomedical is recalling 1,517 units of 13Fr Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2019·2018-10-24

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2019·2018-10-24

    OriGen Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0021-2018·2017-11-01

    OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation

    OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.

    Product
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1456-2015·2015-04-29

    OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk

    OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal
    Category
    Medical Device
    Distribution
    Distributed nationwide