Food, drugs, devices › OriGen Biomedical, Inc.

Device recall: Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F,

FDA enforcement event 81098 · Class II · initiated 21 Aug 2018 · status Terminated · terminated 5 Oct 2021

DeviceVoluntary: Firm initiated1 product recordAustin, TX

FDA enforcement event 81098 is a device recall by OriGen Biomedical, Inc. of Austin, TX, initiated 21 Aug 2018 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 5 Oct 2021. Initiation: voluntary: firm initiated. OriGen Biomedical, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

OriGen Biomedical, Inc., Austin, TX.

Reason for recall

"The catheter failed the endotoxin testing."

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, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0102-2019	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO	106	Class II	Terminated	24 Oct 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for OriGen Biomedical, Inc.

Initiated	Product (first record)	Type	Class	Records
19 Dec 2023	Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a	Device	Class II	1
28 Jan 2021	Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and conta	Device	Class III	1
24 Jun 2019	3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only	Device	Class II	1
21 Aug 2018	Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F,	Device	Class II	6
2 Aug 2017	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of	Device	Class I	1
17 Jan 2017	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F	Device	Class I	6
30 Mar 2015	REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen	Device	Class I	1
30 Mar 2015	OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedi	Device	Class I	1

All 9 events for OriGen Biomedical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The catheter failed the endotoxin testing."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.