CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing recalled
Circulatory Technology is recalling The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, distributed in Louisiana, Michigan, New York, Ohio, Oregon, Texas. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2832-2016
- FDA event ID
- 74991
- Recalling firm
- Circulatory Technology, Oyster Bay, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2016
- FDA classified
- 15 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2016 | Recall initiated by company | |
| 15 Sep 2016 | Classified by FDA | +76 days |
| 21 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seal between the balloon and the housing may leak.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Where it was distributed
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Questions about this recall
Is The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing recalled?
Yes. Circulatory Technology recalled The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing on 1 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2832-2016.
Why was it recalled?
The seal between the balloon and the housing may leak.
Which lots are affected?
Lot # 014648 USE BY: 09/01/2018
Where was it sold?
US Distribution to states of: LA, MI, NY, OH, OR & TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Circulatory Technology
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Better-Bladder (BB), part of extracorporeal membrane recalled | Circulatory Technology | Other | Nationwide |
| Device | CLASS II | Better-Bladder cardiopulmonary bypass blood reservoir recalled | Circulatory Technology | Sterility | 20 states |
| Device | CLASS II | **Expanded to add these recalled by Circulatory Technology | Circulatory Technology | Sterility | 20 states |
| Device | CLASS III | The Better-Bladder With 14" ID tubing recalled by Circulatory Technology | Circulatory Technology | Sterility | Nationwide |
| Device | CLASS II | Bigger-Better-Bladder With 3/8" ID tubing recalled | Circulatory Technology | Packaging Defects | 7 states |
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