Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 30, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
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. Routin…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bridge to Life Ltd recalled Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% … - a moderate-severity action.
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% … was recalled by Bridge to Life Ltd in July 30, 2025. Reason: The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dos…. Check the official notice for the remedy. Verify recall #Z-2157-2025 with the FDA Devices before acting.
The recall
Bridge to Life Ltd issued this moderate-severity FDA Devices recall-The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dos….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- July 30, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2157-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2157-2025) was formally reported on July 30, 2025, with the manufacturer initiating the action on June 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Bridge to Life Ltd is listed as the recalling firm, operating out of Northbrook, IL. Federal records list the affected scope as 4528 units.
The documented reason for this recall is: 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 prope… Distribution data in the federal record shows the product reached: United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4528 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2157-2025 |
| Date reported | July 30, 2025 |
| Date initiated | June 12, 2025 |
| Recalling firm | Bridge to Life Ltd |
| Firm location | Northbrook, IL |
| Affected scope | 4528 units |
| Distribution | United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2157-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250. Recalled by Bridge to Life Ltd. Units affected: 4528 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2157-2025.
Where was the recalled product distributed? ▼
Distribution: United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2157-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 30, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.