Intravenous Lactated Ringer's Recall Due to Sterility Concerns
B Braun Medical Inc is recalling Lactated Ringer's Injection due to lack of assurance of sterility and potential fluid leakage at weld sites. The affected lots may pose a risk to patients receiving intravenous administration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with potential for sterility loss in an intravenous product. No illnesses or injuries have been reported. The hazard is theoretical (potential leakage, lack of assurance of sterility) rather than confirmed, placing this at Score 3 per the rubric criterion that risk-of-harm products without reported injury score at most 3.
Plain-English summary
B Braun Medical Inc has recalled Lactated Ringer's Injection USP, L 7500, 1000mL Excel Containers due to a lack of assurance of sterility and potential for fluid leakage at weld sites in the container.
The recalled lots are J5C802, J5C917, and J5C918, with an expiration date of 08/31/2027. A total of 74,088 containers were distributed nationwide in the United States.
Because this product is administered directly into the bloodstream via intravenous injection, a loss of sterility could pose a risk to patients. The potential fluid leakage at weld sites could affect the integrity of the product.
Patients and healthcare providers should contact their healthcare provider if they have concerns about the affected product. Healthcare facilities should consult with B Braun Medical Inc or the FDA for guidance regarding the recalled lots.
The recalled product
- Product
- LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
- Brand
- LACTATED RINGERS
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Fluids
- Hazard
- sterility-loss
- fluid-leakage
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 (4)
- Lot #: J5C802
- J5C917
- J5C918
- Exp. 08/31/2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LACTATED RINGERS
- SevereLactated Ringers Injection Recalled for Particulate Matter Contamination
FDA (Drugs) · 2026-05-13
- SeverePrescription Lactated Ringers Injection Recalled for Particulate Matter
FDA (Drugs) · 2025-09-10
- HighLactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage
FDA (Drugs) · 2024-04-10
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27