Circulatory Technology Inc.

FDA recalling firm · 5 enforcement events · 6 product records · 2016–2021 · NY

Circulatory Technology Inc. has 5 FDA enforcement events on this register (6 product records) between 2016 and 2021: 5 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
27 Apr 2021	The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14	Device	Class II	1	Ongoing
22 Sep 2017	Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)	Device	Class II	2	Terminated
1 Jul 2016	The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is…	Device	Class II	1	Terminated
1 Jul 2016	The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.	Device	Class III	1	Terminated
3 Mar 2016	Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38	Device	Class II	1	Terminated

By type and class

Device5

Class II4

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Circulatory Technology Inc. by year initiated.

Questions and answers

How many FDA recalls has Circulatory Technology Inc. had?

5 enforcement events (6 product records) on this register, 2016–2021: 5 device.

Are any Circulatory Technology Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Circulatory Technology Inc. recalls?

4 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.