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OriGen Biomedical Recalls
19 recalls on record · April 29, 2015 to February 21, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 21, 2024Medical DevicesFDA
OriGen Biomedical, Inc. recalls Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a
Hazard: 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.
April 21, 2021Medical DevicesFDA
OriGen Biomedical, Inc. recalls Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and c
Hazard: It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
November 11, 2020Medical DevicesFDA
OriGen Biomedical, Inc. recalls 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Hazard: The firm has become aware that they have distributed product that was expired.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Hazard: 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.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Hazard: 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.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Hazard: 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.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
Hazard: 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.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
Hazard: 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.
June 12, 2019Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Hazard: 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.
November 14, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The Or
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula i
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannu
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula i
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F,
Hazard: 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
October 24, 2018Medical DevicesFDA
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F,
Hazard: The catheter failed the endotoxin testing.
November 1, 2017Medical DevicesFDA
OriGen Biomedical, Inc. recalls The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of
Hazard: 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).
April 29, 2015Medical DevicesFDA
OriGen Biomedical, Inc. recalls OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedi
Hazard: 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.