CLASS II ONGOING Drug recall · Reported 24 Sep 2025 · FDA Enforcement Report
0.9% Sodium Chloride Irrigation recalled by B Braun Medical
B Braun Medical is recalling 0.9% Sodium Chloride Irrigation USP, distributed nationwide in the US. The recall was initiated on 26 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0653-2025
- FDA event ID
- 97477
- Recalling firm
- B Braun Medical, Allentown, PA
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2025
- FDA classified
- 16 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Aug 2025 | Recall initiated by company | |
| 16 Sep 2025 | Classified by FDA | +21 days |
| 24 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Which lots are affected?
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97477| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile Water For Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
More recalls from B Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Sodium Chloride For Irrigation recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 0.9 % Sodium Chloride Irrigation recalled by B Braun MedicalSodium Chloride For Irrigation | B Braun Medical | Sterility | Nationwide |