B. Braun Medical Inc: 43 FDA recall reports
Every drug recall the FDA has published for B. Braun Medical Inc. The fault, and how the agency graded it.
43Reports
19Class I
14Ongoing
2026-05-13Most recent
19 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524
D-0540-2026 · Class I · reported 2026-05-13 · Ongoing
- Why it was recalled
- Presence of Particulate Matter.
- Product
- Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
- Where it went
- U.S.A. Nationwide
- How much
- 95,412 containers
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524,
D-0496-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Product
- DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
- Where it went
- US Nationwide.
- How much
- 17,124 bags
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524,
D-0498-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Product
- LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- Where it went
- US Nationwide.
- How much
- 54,540 bags
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18
D-0497-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Product
- 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
- Where it went
- US Nationwide.
- How much
- 124,244 bags
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehe
D-0495-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Product
- Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
- Where it went
- US Nationwide.
- How much
- 24,928 bags
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc.,
D-0653-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Product
- 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
- Where it went
- U.S. Nationwide
- How much
- 16,228 3000 mL bags
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60
D-0652-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Product
- STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Where it went
- U.S. Nationwide
- How much
- 26,316 3000 mL bags
Class I
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-35
D-0628-2025 · Class I · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of Particulate Matter.
- Product
- 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
- Where it went
- U.S.A. Nationwide
- How much
- 47,148 containers
Class I
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524
D-0627-2025 · Class I · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of Particulate Matter
- Product
- Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
- Where it went
- U.S.A. Nationwide
- How much
- 46,032 containers
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dos
D-0586-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Product
- 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
- Where it went
- Nationwide in the US
- How much
- 23,100 containers
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose c
D-0585-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Product
- Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
- Where it went
- Nationwide in the US
- How much
- 74,088 containers
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per ca
D-0491-2025 · Class II · reported 2025-07-02 · Ongoing
- Why it was recalled
- Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
- Product
- 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
- Where it went
- USA Nationwide
- How much
- 187,656 containers
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PI
D-0353-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- Presence of Particulate Matter
- Product
- 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
- Where it went
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
- How much
- 32,256 Bottles
Class I
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0
D-0638-2024 · Class I · reported 2024-08-28 · Ongoing
- Why it was recalled
- Presence of Particulate Matter
- Product
- 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
- Where it went
- Nationwide within U.S.A
- How much
- 63,444 containers
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018,
D-0431-2024 · Class II · reported 2024-04-10 · Terminated
- Why it was recalled
- Lack of assurance of sterility: bags have the potential to leak..
- Product
- Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
- Where it went
- Nationwide in the USA
- How much
- 7,800 bags
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Med
D-0370-2024 · Class II · reported 2024-03-20 · Terminated
- Why it was recalled
- Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- Product
- Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
- Where it went
- Nationwide in the USA
- How much
- 22,752 bags
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA
D-1083-2023 · Class III · reported 2023-08-16 · Terminated
- Why it was recalled
- Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- Product
- 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
- Where it went
- United States
- How much
- 43,812 bags
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA
D-0916-2023 · Class II · reported 2023-07-19 · Terminated
- Why it was recalled
- Lack of assurance of sterility: bags have the potential to leak.
- Product
- 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
- Where it went
- USA Nationwide
- How much
- 79,880 bags
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Con
D-0579-2023 · Class II · reported 2023-05-24 · Terminated
- Why it was recalled
- Subpotent: Low anti-factor IIa Potency.
- Product
- Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
- Where it went
- Nationwide in the USA
- How much
- 1,380
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Cont
D-0434-2023 · Class II · reported 2023-03-15 · Terminated
- Why it was recalled
- Subpotent Drug: low Anti-Factor IIa potency.
- Product
- Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
- Where it went
- Nationwide in the USA
- How much
- 30672
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA
D-0347-2023 · Class II · reported 2023-03-01 · Completed
- Why it was recalled
- Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
- Product
- 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
- Where it went
- USA Nationwide.
- How much
- 483,229 bags
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, P
D-0346-2023 · Class II · reported 2023-03-01 · Completed
- Why it was recalled
- Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
- Product
- 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
- Where it went
- USA Nationwide.
- How much
- 1,343,982 bags
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc
D-0076-2023 · Class II · reported 2022-12-14 · Terminated
- Why it was recalled
- Lack of sterility assurance: Bags have the potential to leak.
- Product
- 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
- Where it went
- FL, NJ, PA
- How much
- 756 bags
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC
D-0655-2022 · Class II · reported 2022-03-23 · Terminated
- Why it was recalled
- Lack of sterility assurance: leaking bags
- Product
- 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
- Where it went
- USA Nationwide
- How much
- 33,742 bags
Class I
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Me
D-1257-2020 · Class I · reported 2020-05-06 · Terminated
- Why it was recalled
- Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
- Product
- Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
- Where it went
- Product was distributed nationwide within the United States.
- How much
- 22,488 Duplex containers
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Conta
D-1343-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
- Product
- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
- Where it went
- Nationwide in the USA
- How much
- 40,176 bags
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc
D-0549-2018 · Class II · reported 2018-03-07 · Terminated
- Why it was recalled
- Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
- Product
- 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
- Where it went
- Nationwide in the USA
- How much
- 17,360 plastic irrigation containers
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 9
D-0112-2018 · Class II · reported 2017-12-27 · Terminated
- Why it was recalled
- Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- Product
- 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
- Where it went
- Product was distributed nationwide.
- How much
- 2,576 containers
Class I
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-58
D-0094-2017 · Class I · reported 2016-10-19 · Terminated
- Why it was recalled
- Non-Sterility: fungal contamination due to leaking containers.
- Product
- 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
- Where it went
- Nationwide
- How much
- 57,408 units
Class I
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Us
D-1264-2014 · Class I · reported 2014-05-07 · Terminated
- Why it was recalled
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Product
- Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
- Where it went
- Nationwide, Puerto Rico and Spain
- How much
- 22,584 units
Showing the 30 most recent of 43. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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