Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bigger-Better-Bladder With 3/8" ID tubing Recalled by Circulatory Technology Inc Due to The seal between the balloon and the housing...

Date: March 3, 2016
Company: Circulatory Technology Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Circulatory Technology Inc directly.

Affected Products

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Quantity: 72 units

Why Was This Recalled?

The seal between the balloon and the housing may leak.

Where Was This Sold?

This product was distributed to 7 states: CA, IN, MI, NY, PA, TX, VA

Affected (7 states)Not affected

About Circulatory Technology Inc

Circulatory Technology Inc has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report