Bioseal recalls

Bioseal has 5 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 26 May 2021. The most frequent reason is sterility.

Total recalls5since 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 26 May 2021

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 5 100%Class III 0 0%

Why bioseal is recalled

Sterility480%
Other Reasons120%

Product types

By year

2021360%
2020120%
2017120%

All bioseal recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
26 May 2021Device	CLASS II	Chest Tube Insertion Tray, containing ChloraPREP Applicator recalled	Bioseal	Sterility	IL, MO
26 May 2021Device	CLASS II	Central Line Dressing Kit, containing ChloraPREP Applicator recalled	Bioseal	Sterility	IL, MO
26 May 2021Device	CLASS II	Central Line Dressing Kit, containing ChloraPREP Applicator recalled	Bioseal	Sterility	IL, MO
19 Aug 2020Device	CLASS II	Trachea Extender 1/pl/Cs recalled by Bioseal	Bioseal	Sterility	Nationwide
15 Nov 2017Device	CLASS II	Custom surgical kits labeled as follows recalled by Bioseal	Bioseal	Other	4 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.