Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage
B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.
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 3/5 (High).
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: This FDA Class II recall involves a high-risk intravenous product where sterility failure could lead to serious infection. However, no illnesses or injuries have been reported, and the hazard is theoretical (potential leakage) rather than confirmed. Per the rubric, products with risk of harm but no reported injury score at most 3.
Plain-English summary
B. Braun Medical Inc. is recalling Lactated Ringers Injection USP, a sterile intravenous solution supplied in 1000mL EXCEL containers. The affected product is Lot J3N023 with an expiration date of March 31, 2026, distributed nationwide in the United States. Approximately 7,800 bags are subject to this recall.
The recall was initiated due to lack of assurance of sterility. The bags have the potential to leak, which could compromise the sterile integrity required for intravenous administration.
Lactated Ringers is an electrolyte solution used in medical settings for intravenous fluid replacement. The potential for bag leakage could allow contamination of the product.
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 Solution
- Hazard
- Affected units
- 7,800
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 (2)
- Lot #: J3N023
- Exp: 31 March 2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LACTATED RINGERS
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereLactated Ringers Injection Recalled for Particulate Matter Contamination
FDA (Drugs) · 2026-05-13
- CriticalLactated Ringer's injection containers recalled over presence of particulate matter
FDA (Drugs) · 2025-09-10
- HighLactated Ringer's containers may leak at a weld site
FDA (Drugs) · 2025-08-20
- CriticalBaxter Recalls Lactated Ringers Bags Due to Metal Particulate Matter
FDA (Drugs) · 2015-07-15
Same manufacturer · B. Braun Medical Inc
See all →- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- 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 failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- ModerateLactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern
FDA (Drugs) · 2026-04-29
- HighLactated Ringer's containers may leak at a weld site
FDA (Drugs) · 2025-08-20
- SevereLactated Ringers Injection Recalled for Particulate Matter Contamination
FDA (Drugs) · 2026-05-13
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalLactated Ringer's injection containers recalled over presence of particulate matter
FDA (Drugs) · 2025-09-10
- HighLactated Ringers IV Solution Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-02-22