Food, drugs, devices › Circulatory Technology Inc
Device recall: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA enforcement event 73608 is a device recall by Circulatory Technology Inc of Oyster Bay, NY, initiated 3 Mar 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 20 Apr 2017. Initiation: voluntary: firm initiated. Circulatory Technology Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Circulatory Technology Inc, Oyster Bay, NY.
Reason for recall
"The seal between the balloon and the housing may leak."
Distribution
"US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2050-2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | 72 units | Class II | Terminated | 6 Jul 2016 |
Context
Other enforcement events for Circulatory Technology Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Apr 2021 | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 | Device | Class II | 1 |
| 22 Sep 2017 | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk | Device | Class II | 2 |
| 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 trand | Device | Class II | 1 |
| 1 Jul 2016 | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit | Device | Class III | 1 |
All 5 events for Circulatory Technology Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The seal between the balloon and the housing may leak."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.