B. Braun Medical Inc. recalled 16,228 3000 mL saline irrigation bags nationwide in the United States. The recall cites lack of assurance of sterility due to port misalignment, creating a potential for fluid leakage. Healthcare providers and patients should stop using the product immediately and contact the company for guidance.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
0.9% Sodium Chloride Irrigation USP is used for sterile irrigation in medical settings. It is sold as 3000 mL bags for Rx use.
The port misalignment can lead to leakage and potential breach of sterility, posing infection or contamination risks.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to quarantine affected lots while awaiting guidance; patients may experience delays in sterile irrigation care.
Recall notice letters and FDA enforcement report D-0653-2025.
Refunds or replacements will be handled via notification by mail; processing timelines vary.
Keep recall notification letter, photos of packaging, lot numbers, and correspondence with vendor
Product: 0.9% Sodium Chloride Irrigation USP Isotonic Solution for Irrigation, 3000 mL, Rx only. Brand: Sodium Chloride for Irrigation. NDC: 0264-7388-60. Models: J4C521, J4C516, J4C524. Quantity: 16,228 bags. Sold nationwide in the U.S. by unknown distributors. Status: Active recall as of 2025-09-24. Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018, USA.
No incidents or injuries are reported in the provided data.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.
B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.
B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.
B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.