Recall Register

Food, drugs, devices › Firms

OriGen Biomedical, Inc.

FDA recalling firm · 9 enforcement events · 19 product records · 2015–2023 · TX

OriGen Biomedical, Inc. has 9 FDA enforcement events on this register (19 product records) between 2015 and 2023: 9 device; the busiest year was 2015 with 2.

44% of its events are Class I; the most common class is Class I (4). 1 event is listed as ongoing; the recalling firm's address is in TX.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
19 Dec 2023Accessory 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-TDeviceClass II1Ongoing
28 Jan 2021Evolve 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, PVC tubing, Yconnectors, needle-free…DeviceClass III1Terminated
24 Jun 20193/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx OnlyDeviceClass II1Terminated
21 Aug 2018Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EODeviceClass II1Terminated
21 Aug 2018Reinforced 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 in the internal jugular vein during…DeviceClass II6Terminated
2 Aug 2017The 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.DeviceClass I1Terminated
17 Jan 2017ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16FDeviceClass I6Terminated
30 Mar 2015REF 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 extracorporeal life support procedures of six…DeviceClass I1Terminated
30 Mar 2015OriGen 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 jugular vein during extracorporeal life…DeviceClass I1Terminated

By type and class

Device9
Class I4
Class II4
Class III1

Class I: 44% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for OriGen Biomedical, Inc. by year initiated.

Questions and answers

How many FDA recalls has OriGen Biomedical, Inc. had?

9 enforcement events (19 product records) on this register, 2015–2023: 9 device.

Are any OriGen Biomedical, Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are OriGen Biomedical, Inc. recalls?

4 Class I, 4 Class II, 1 Class III. 44% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.