FDA company announcement
B. Braun: 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Presence of particulate matter identified as iron oxide
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
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B. Braun Medical, Inc. recall records
240 reported ongoing
258 records in this archive. Latest source date Sep 3, 2026. 4 published notices do not supply a closure status.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for B. Braun: 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
FDA drug enforcement
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class IReported ongoing
Distribution: Nationwide within the United States
FDA drug enforcement
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
Presence of Particulate matter.
Class IReported ongoing
Distribution: U.S. Nationwide
FDA device enforcement
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada.
FDA device enforcement
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24...
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspe...
Class IReported ongoing
Distribution: US Nationwide distribution.
FDA device enforcement
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Sp...
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspe...
Class IReported ongoing
Distribution: US Nationwide distribution.
FDA device enforcement
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINA...
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspe...
Class IReported ongoing
Distribution: US Nationwide distribution.
FDA drug enforcement
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Presence of Particulate Matter.
Class IReported ongoing
Distribution: U.S.A. Nationwide
FDA company announcement
B. Braun: Lactated Ringer’s Injection, E7500, 1L
Products were found to contain particulate matter in solution
Not suppliedPublished notice; closure not supplied
Distribution: The product can be identified by product code E7500 or NDC 0264-7750-07. Product was distributed Nationwide to distributors, hospital, and healthcare facilities.
FDA drug enforcement
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.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class IIReported ongoing
Distribution: US Nationwide.
FDA drug enforcement
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class IIReported ongoing
Distribution: US Nationwide.
FDA drug enforcement
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.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class IIReported ongoing
Distribution: US Nationwide.
FDA drug enforcement
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class IIReported ongoing
Distribution: US Nationwide.
FDA device enforcement
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
FDA device enforcement
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneou...
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
Reasons in these listed records
- Presence of particulate matter identified as iron oxide
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Presence of Particulate matter.
- Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
These examples come from this result page and are not a ranking of every recall reason.
Checking B. Braun Medical, Inc.
Is there a recall on b. braun medical, inc. right now?
This archive contains 258 records, including 240 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
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Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.