Circulatory Technology recalls

Circulatory Technology has 6 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 23 Jun 2021. 1 is still ongoing. The most frequent reason is sterility.

Total recalls6since 2016

Last 12 months0reported

Class I00% of total

Ongoing1latest 23 Jun 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 83%Class III 1 17%

Why circulatory technology is recalled

Product types

Other Medical Devices583%
Heart & Vascular Devices117%

By year

2021117%
2018233%
2016350%

Ongoing circulatory technology recalls

1 active

Reported	Class	Recall	Company	Reason	Where
23 Jun 2021Device	CLASS II	The Better-Bladder (BB), part of extracorporeal membrane recalled	Circulatory Technology	Other	Nationwide

All circulatory technology recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
23 Jun 2021Device	CLASS II	The Better-Bladder (BB), part of extracorporeal membrane recalled	Circulatory Technology	Other	Nationwide
7 Mar 2018Device	CLASS II	Better-Bladder cardiopulmonary bypass blood reservoir recalled	Circulatory Technology	Sterility	20 states
7 Mar 2018Device	CLASS II	**Expanded to add these recalled by Circulatory Technology	Circulatory Technology	Sterility	20 states
19 Oct 2016Device	CLASS III	The Better-Bladder With 14" ID tubing recalled by Circulatory Technology	Circulatory Technology	Sterility	Nationwide
21 Sep 2016Device	CLASS II	The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing recalled	Circulatory Technology	Packaging Defects	6 states
6 Jul 2016Device	CLASS II	Bigger-Better-Bladder With 3/8" ID tubing recalled	Circulatory Technology	Packaging Defects	7 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.