Bridge to Life Ltd: Medical Device Recall in 2025 - (Recall #: Z-2157-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 12, 2025

Date Posted: July 30, 2025

Recall Number: Z-2157-2025

Event ID: 97143

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 4528 units

Code Information:

UDI 10860001991205-240206-260206-240372708 (case), 00860001991208-240206-260206-240372708 (bag), Lot Number 240372708; UDI 10860001991205-240212-260212-240402836 (case), 00860001991208-240212-260212-240402836 (bag), Lot Number 240402836; UDI 10860001991205-240214-260214-240402837 (case), 00860001991208-240214-260214-240402837 (bag), Lot Number 240402837.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated