Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported September 24, 2025
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
B Braun Medical INC recalled 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B… - a moderate-severity action.
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B… was recalled by B Braun Medical INC in September 24, 2025. Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.. Check the official notice for the remedy. Verify recall #D-0653-2025 with the FDA Drug before acting.
The recall
B Braun Medical INC issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment..
- Moderate
- severity level
- Class II
- classification
- September 24, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0653-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0653-2025) was formally reported on September 24, 2025, with the manufacturer initiating the action on August 26, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. B Braun Medical INC is listed as the recalling firm, operating out of Allentown, PA. Federal records list the affected scope as 16,228 3000 mL bags.
The documented reason for this recall is: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. Distribution data in the federal record shows the product reached: U.S. Nationwide. 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, 5 from FDA Drug - 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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
16,228 3000 mL bags
Related Recalls
6
5 from same agency
Product description
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0653-2025 |
| Date reported | September 24, 2025 |
| Date initiated | August 26, 2025 |
| Recalling firm | B Braun Medical INC |
| Firm location | Allentown, PA |
| Affected scope | 16,228 3000 mL bags |
| Distribution | U.S. Nationwide |
Profile values are sourced directly from the official FDA Drug 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 (D-0653-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug 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 Drug 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? ▼
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.. Recalled by B Braun Medical INC. Units affected: 16,228 3000 mL bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2025. Severity: Moderate. Recall number: D-0653-2025.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0653-2025) against your product. Visit the official FDA Drug 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
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Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 Drug, reported September 24, 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.