Class II — Potential Health Hazard

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

Bridge to Life EasiSlush Recalled by Bridge to Life Ltd Due to The firm issued a field safety notice after...

Date: June 12, 2025
Company: Bridge to Life Ltd
Status: Ongoing
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 Bridge to Life Ltd directly.

Affected Products

Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

Quantity: 4528 units

Why Was This Recalled?

The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

Where Was This Sold?

United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada

About Bridge to Life Ltd

Bridge to Life Ltd has 1 total recall tracked by RecallDetector.

Related Recalls

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