OriGen Biomedical, Inc. recalls
Every recall we track for OriGen Biomedical, Inc. — 11 in all, from 2017–2023 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from OriGen Biomedical, Inc. peaked in 2018 (7); 11 since 2017. 9% rated “stop using now”.
All FDA recall records for OriGen Biomedical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 0 | 0 | 1 |
| 2018 | 0 | 0 | 6 | 1 | 7 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled OriGen Biomedical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All OriGen Biomedical, Inc. recalls
6 shown- Lower riskMedical device
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
OriGen recalls 6ml and 60ml syringes with yellowed tubing due to gamma sterilization issues. These syringes may not function safely for medical use. Affected units have specific reference numbers.
OriGenDec 19, 2023 - Lower riskMedical device
OriGen Biomedical, Inc. recalls Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and
OriGen Biomedical recalls Evolve Cell Culture Bags (EV1000N, EV3000N) due to incorrect labeling as phthalate-free. These bags are made of EVO and contain no BPA or latex.
OriGen BiomedicalJan 28, 2021 - Lower riskMedical device
OriGen Biomedical, Inc. recalls 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
OriGen Biomedical recalls expired 3/8" FloPump pumps. These sterile medical devices may not be safe for use after expiration. Consumers should check product lot numbers and contact the company for details.
OriGen BiomedicalJun 24, 2019 - UnratedMedical device
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF:
OriGen Biomedical recalls reinforced dual lumen cannulas due to failed endotoxin testing. Affected units have specific model and lot numbers. Consumers should contact for details.
OriGen BiomedicalAug 21, 2018 - Lower riskMedical device
OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is
OriGen recalls 32Fr Reinforced Dual Lumen Cannulas (REF: VV3: VV32F) due to potential barium sulfate omission and incorrect tip length. This affects medical use in extracorporeal life support.
OriGenAug 21, 2018 - Stop using nowMedical device
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
OriGen recalls Reinforced Dual Lumen catheters with lot numbers N18487 and N18487-1 due to risk of clear tube separation causing blood loss. Affected patients should contact for remedy.
OriGenAug 2, 2017
OriGen Biomedical, Inc. recall questions
How many recalls has OriGen Biomedical, Inc. had?
11 recalls from OriGen Biomedical, Inc. are on record with U.S. safety agencies, from 2017–2023.
What is the most recent OriGen Biomedical, Inc. recall?
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, dated Dec 19, 2023. Every OriGen Biomedical, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled OriGen Biomedical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new OriGen Biomedical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.