BD Becton, Dickinson and Company and Fresenius Kabi USA recall 0.9% Sodium Chloride Injection, USP, 250 mL in a single-dose bag nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately and follow guidance from Fresenius Kabi or their provider.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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IV saline solution supplied in single-dose freeflex bags is used to restore fluid balance in patients. It is distributed nationwide and used in hospitals and clinics.
Lack of assurance of sterility means the solution could be contaminated with bacteria or other pathogens, posing infection risk to patients.
This recall is not described as part of a broader industry pattern in the provided material.
Immediate action required for healthcare facilities to prevent potential infections. No reported injuries yet, but breaches in sterility could have severe consequences in clinical settings.
FDA enforcement notice for D-0431-2026 and manufacturer communications
Refund or replacement timelines not specified in provided data; recipients should follow recall notice guidance and contact supplier for status
Retain lot numbers, batch IDs, expiry dates, procurement records, and all communications with supplier.
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag. Sold Rx only. Distributor: BD Becton, Dickinson and Company. Manufactured by: Fresenius Kabi USA, LLC. NDC: 17271-701-05. Distribution: US nationwide including Alaska and Puerto Rico. Class II recall. Recall date: 2026-03-11. Report date: 2026-04-15.
No injuries or incidents have been reported.
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Fresenius Kabi USA recalled 0.9% Sodium Chloride Injection nationwide, including Alaska and Puerto Rico. The recall is due to lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Fresenius Kabi for guidance.
Fresenius Kabi USA recalls 0.9% Sodium Chloride Injection units distributed nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers should stop use and contact Fresenius Kabi for guidance.
BD and Fresenius Kabi recall 1,000 mL sodium chloride injection due to lack of assurance of sterility. The U.S. distribution covers nationwide, Alaska, and Puerto Rico. Health care providers should stop use and seek guidance from Fresenius Kabi or a clinician immediately.
Fresenius Kabi USA recalled saline injections distributed nationwide, including Alaska and Puerto Rico. The action covers multiple batch numbers with sterility concerns. Healthcare providers and patients should stop using the product immediately and follow official guidance for replacement options.