B Braun Medical Inc

FDA Regulatory Profile

B Braun Medical Inc appears in FDA public data with 199 recalls — including 22 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2276-2026, Class I) was initiated on May 6, 2026.

Summary

Total Recalls
199 (22 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

b. braun medical, b braun medical

Recent Recalls

NumberClassProductDate
Z-2276-2026Class ISpinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAMay 6, 2026
Z-2277-2026Class ISpinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x May 6, 2026
Z-2278-2026Class IDesign Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (MaterialMay 6, 2026
D-0540-2026Class ILactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 1April 28, 2026
D-0498-2026Class IILACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 1April 2, 2026
D-0495-2026Class IISterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc.April 2, 2026
D-0496-2026Class IIDEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18April 2, 2026
D-0497-2026Class II0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., BethleApril 2, 2026
Z-1799-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096March 19, 2026
Z-1798-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M20March 19, 2026
Z-1801-2026Class IB. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095March 19, 2026
Z-1802-2026Class IB. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705March 19, 2026
Z-1800-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.March 19, 2026
Z-1803-2026Class IB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.March 19, 2026
Z-1481-2026Class IIBrand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B30February 2, 2026
Z-1483-2026Class IIBrand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software VersFebruary 2, 2026
Z-1482-2026Class IIBrand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 SFebruary 2, 2026
Z-2266-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498January 29, 2026
Z-2270-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog NumbeJanuary 29, 2026
Z-2268-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number:January 29, 2026