Bridge to Life EasiSlush — Class II medical device recall Z-2157-2025
Ongoing recall by Bridge to Life Ltd, reported 2025-07-30, distributed in AL, AZ, CA, FL, GA, MD, MN, NC…. The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose
| Recall number | Z-2157-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bridge to Life Ltd, Northbrook, IL, United States |
| Recall initiated | 2025-06-12 |
| Classified | 2025-07-22 |
| Reported by FDA | 2025-07-30 |
| Distributed | AL, AZ, CA, FL, GA, MD, MN, NC, NE, NJ, NY, OH, SC, TN, UT, WI |
| Countries outside the US | CA |
| Quantity | 4,528 units |
| Reason classes | sterility |
| Lot numbers | 240372708, 240402836, 240402837 |
| Model numbers | BTLE-1250 |
Product
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2157-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.