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OriGen Biomedical Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000018098 FEI 3042484745

Devices
296
Registrations
EUDAMEDFDA
FDA recalls
201 ongoing

Catalogue296

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  • PermaLife™ Cell Culture Bag Ref PL70-2G

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore 25 Freezing Bag Ref CS25NS

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS50NS

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore 25 Freezing Bag Ref CS25F

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL30K

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Spike Adapters Ref CBS

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoStore Freezing Bags Ref CS250

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL30T

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore 25 Freezing Bag Ref CS25XN

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoStore Freezing Bags Ref CS250NSW

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Conical Freezing Bag Ref CSD2500Y14

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL120K

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Syringes Ref 15-RF60-T

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS2000N

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Spike Adapters Ref S-F50

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS1000N

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore 25 Freezing Bag Ref CS25N

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • O-Wrap™ Bag Ref OW0909

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS28V

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Spike Ref IBS

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoPur™ Solutions Ref CD-50

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoStore 25 Freezing Bag Ref CS25NSW

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS750

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Manifold Sets Ref 40-PF-2M

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS50

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS500NSW

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL120T

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • O-Wrap™ Bag Ref OW1936

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS750KS

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL2000K

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS500N

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Cell Connect™ Ref CC2

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoPur™ Solutions Ref SP-10

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • CryoPur™ Solutions Ref SP-50

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL500P-2G

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Manifold Sets Ref F-8S100

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL750T

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL07-2G

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoStore Freezing Bags Ref CS750NS

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Syringes Ref R3F-T15

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL240K

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Spike Adapters Ref VSV

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • TissueVault™ Cell & Tissue Freezing Bag Ref TV0909

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL30M

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • CryoPur™ Solutions Ref CP-10

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PermaLife™ Cell Culture Bag Ref PL1000P

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

Rows 251-296 of 296

Showing 251-296 of 296

Company details

EUDAMED SRN
US-MF-000018098
FDA FEI number
3042484745
DUNS number
625272232
EU VAT number
NL825807803B01
EUDAMED status
Active
EUDAMED registered name
OriGen Biomedical Inc.
EUDAMED abbreviated name
OriGen Biomedical Inc.
Registered address
2215, Grand Avenue Parkway, 78728, Austin, United States
Phone
+1 512-474-7278
PRRC contact
Sam Saleh(public in EUDAMED)

FDA recalls20

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 7
  • 2018 7
  • 2019 1
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

3 initiated before 2017

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. Distribution: US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE

  • 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. Distribution: US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None

  • 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. Distribution: US: TX Submission number: K170029

  • 2018

    • 21 Aug 2018 Z-0102-2019 Class II Terminated The catheter failed the endotoxin testing.via FDA establishment OriGen Biomedical, Inc. Distribution: US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD,…
      Full distribution text US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL,…
      Full distribution text Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
      Submission number: K113869
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. Distribution: US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands,…
      Full distribution text US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869
    • 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. Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT,…
      Full distribution text US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
      Submission number: K113869

  • 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. Distribution: Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom
      Submission number: K113869
    • 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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands. Submission number: K113869

  • 2002

    • 16 Dec 2002 Z-0055-06 Unclassified (pre-2012) Terminated Leak between two lumens causes reduced performance.via FDA establishment OriGen Biomedical, Inc. Distribution: The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI,…
      Full distribution text The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.

FDA establishments1

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

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

From the company website

Read 18 Oct 2026

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 19 Dec 2023. 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.