OriGen Biomedical recalls

OriGen Biomedical has 19 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 21 Feb 2024. 1 is still ongoing. The most frequent reason is sterility.

Total recalls19since 2015

Last 12 months0reported

Class I947% of total

Ongoing1latest 21 Feb 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 9 47%Class II 9 47%Class III 1 5%

Why origen biomedical is recalled

Product types

By year

202415%
202115%
202015%
2019632%
2018842%
201715%
201515%

Ongoing origen biomedical recalls

1 active

Reported	Class	Recall	Company	Reason	Where
21 Feb 2024Device	CLASS II	Accessory Sets Syringes: syringe with a female luer recalled	OriGen Biomedical	Sterility	11 states

All origen biomedical recalls, newest first

19 total

Reported	Class	Recall	Company	Reason	Where
21 Feb 2024Device	CLASS II	Accessory Sets Syringes: syringe with a female luer recalled	OriGen Biomedical	Sterility	11 states
21 Apr 2021Device	CLASS III	Evolve Cell Culture, part numbers: EV1000N recalled by OriGen Biomedical	OriGen Biomedical	Labeling Errors	19 states
11 Nov 2020Device	CLASS II	3/8" FloPump, (Sterile) recalled by OriGen Biomedical	OriGen Biomedical	Sterility	TX
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
14 Nov 2018Device	CLASS I	REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO recalled	OriGen Biomedical	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.