AROA Biosurgery recalls

AROA Biosurgery has 24 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 21 Nov 2018. The most frequent reason is potency & assay.

Total recalls24since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Nov 2018

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 0 0%Class II 24 100%Class III 0 0%

Why aroa biosurgery is recalled

Potency & Assay2188%
Sterility313%

Product types

Other Medical Devices24100%

By year

201824100%

All aroa biosurgery recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
21 Nov 2018Device	CLASS II	OviTex 1S Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex Reinforced BioScaffold 10x12cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex 1S Reinforced BioScaffold 16x20cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex 1S Reinforced BioScaffold 10x20cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex Reinforced BioScaffold 16x20cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex Reinforced BioScaffold 20x20cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex 1S Reinforced BioScaffold 6x10cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex 2S Reinforced BioScaffold 20x20cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states
21 Nov 2018Device	CLASS II	OviTex 2S Reinforced BioScaffold 6x10cm recalled by AROA Biosurgery	AROA Biosurgery	Potency & Assay	8 states

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.