B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Sterility assurance failure in an intravenous injection poses a direct risk of serious infection or harm if contaminated product is administered, meeting the criteria for a Severe classification even without reported illnesses.
Plain-English summary
B. Braun Medical, Inc. is recalling 0.9% Sodium Chloride Injection USP in 250 mL Excel containers due to a lack of sterility assurance caused by leaking bags. The recalled product (NDC 0264-7800-20) was distributed nationwide.
The specific lots affected are J1E086, J1E204, and J1E213 (expiring 5/31/2023), and J1H137 and J1H138 (expiring 6/30/2023). A total of 33,742 bags have been recalled.
Healthcare professionals and patients using affected lots should contact their pharmacy or healthcare provider. Patients should not use recalled bags and should return them to B. Braun Medical, Inc. or their supplier for replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Drug — Intravenous Injection
- Affected units
- 33,742
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: J1E086
- J1E204
- J1E213
- Exp 5/31/2023
- J1H137
- J1H138
- Exp 6/30/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SODIUM CHLORIDE
- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- CriticalBaxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighFresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Same manufacturer · B. Braun Medical, Inc.
See all →- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- SevereDesign Options spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighSodium Chloride Injection Bags Recalled for Potential Leakage and Sterility Risk
FDA (Drugs) · 2023-07-19
- HighIntravenous Sodium Chloride Injection Recall for Potential Bag Leakage
FDA (Drugs) · 2022-12-14
- HighSodium Chloride Injection Recalled for Incomplete Seal and Potential Leakage
FDA (Drugs) · 2023-03-01
- HighFDA Recalls Sodium Chloride Injection Due to Incomplete Container Seals
FDA (Drugs) · 2023-03-01
- HighSodium chloride injection containers recalled over potential fluid leakage at weld site
FDA (Drugs) · 2025-08-20
- SevereSodium Chloride Injection Recalled for Sterility Assurance Defect
FDA (Drugs) · 2025-07-02