B.Braun Medical, Inc.
B.Braun Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 395 FDA device recalls on record.
Top product codes for B.Braun Medical, Inc.
FDA recalls by B.Braun Medical, Inc.
10 most recent of 395- Z-0193-2027 — B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
- Z-3089-2026 — Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
- Z-2277-2026 — 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); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
- Z-2276-2026 — Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)
- Z-2278-2026 — 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 (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672);
- Z-1801-2026 — B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
- Z-1798-2026 — B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
- Z-1800-2026 — B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- Z-1803-2026 — B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
- Z-1802-2026 — B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by B.Braun Medical, Inc.
1–100 of 151- K260261 — Gravity Blood Sets with 200µm Filter
- K254111 — Irrigation/Urology Sets
- K253235 — Introcan Safety® Deep Access XL IV Catheter
- K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets
- K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- K241845 — Introcan Safety® 2 IV Catheter
- K241385 — Omnifix Syringe NRFit
- K231242 — Perifix FX Catheter; Contiplex FX Catheter
- K223479 — AQUAbase nX
- K220756 — Introcan Safety 2 IV Catheter
- K220626 — Introcan Safety IV Catheter
- K213778 — IV Administration Set
- K213664 — B. Braun Introcan Safety 2 IV Catheter
- K212842 — Microvolume Luer Access Device
- K213085 — Introcan Safety 3 Closed IV Catheter
- K202618 — IV Administration Sets
- K201469 — Mini Spike Plus 6/8R
- K192577 — Actreen Hi-Lite Intermittent Urinary Catheters
- K192676 — Introcan Safety 2 IV Catheter 18-24 gauge
- K191658 — IV Sets not made with PVC
- K193101 — Omnifix Low Dead Space Luer Lock Syringe
- K182870 — Introcan Safety 3 Closed IV Catheter
- K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite Set
- K173531 — Lockbox for Perfusor Space PCA Infusion Pump
- K173361 — IV Administration Set
- K172831 — Perfusor® Space Syringe Infusion Pump System
- K173803 — Omnican fine
- K171584 — B. Braun Tear-Away Introducer Needle
- K170595 — IV Administration Sets
- K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
- K163430 — Prontosan Wound Gel
- K161623 — Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
- K153297 — Perifix and Contiplex Catheter
- K153293 — Extension Set
- K151423 — APEX Compounding System Transfer Set
- K151772 — Actreen Mini Intermittent Urinary Catheters
- K150787 — Universal Spike
- K150800 — Valved Safety Centesis Catheter
- K143082 — IV Administration Sets with 200(micro)m Blood Filter
- K142596 — Infusomat Space Volumetric Infusion Pump
- K140838 — IV ADMINISTRATION SET WITH HAND PUMP
- K142036 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
- K133632 — PERICAN ULTRA
- K140311 — CARESITE LUER ACCESS DEVICE
- K130857 — PRONTOSAN WOUND GEL X
- K131842 — STERICAN CANNULA
- K121846 — CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
- K120150 — DUAL SPIKE TRANSFER DEVICE
- K113059 — CONTIPLEX FX
- K112515 — PENCAN SPINAL NEEDLE
- K112636 — CYTOGUARD(TM) CLOSED LUER CONNECTOR
- K110744 — PRONTOSAN WOUND IRRIGATION SOLUTION
- K101882 — PRONTOSAN ANTIMICROBIAL WOUND GEL
- K100640 — 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
- K100241 — CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K090995 — B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
- K083689 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K090884 — PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
- K083723 — A6 LUER ACCESS DEVICE
- K090905 — ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
- K090141 — PRONTOSAN ANTIMICROBIAL WOUND GEL
- K073396 — ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
- K072876 — PRONTOSAN WOUND IRRIGATION SOLUTION
- K073538 — DUAL CHAMBER TPN CONTAINER
- K072247 — STERICAN HYPODERMIC NEEDLES
- K071459 — B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
- K063282 — CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
- K063217 — VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
- K063280 — INJEKT SYRINGE
- K062699 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K062700 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K052773 — B. BRAUN 0.2 MICRON FILTER
- K052252 — CONTRAST MEDIA TRANSFER SETS
- K052393 — B. BRAUN MODIFIED BICARBONATE DIALYSATE
- K041490 — IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
- K041222 — PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
- K042488 — PERIFIX CATHETER AND CONTIPLEX CATHETER
- K041683 — B. BRAUN BICARBONATE DIALYSATE
- K041415 — EVA TPN CONTAINER
- K034066 — B.BRAUN PREMIXED DIALYSATE
- K033575 — ONE.CLICK NEEDLE
- K033527 — INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
- K033952 — PERIFIX CATHETER CONNECTOR
- K032144 — PERIFIX CATHETER CONNECTOR
- K031923 — ULTRASITE VALVE
- K030135 — SAFETY INTRODUCER NEEDLE
- K030830 — B. BRAUN NERVE BLOCK CATHETER
- K023253 — PEDIATRIC CENTRAL VENOUS CATHETER KIT
- K021033 — STIMUPLEX-DIG-RC NERVE STIMULATOR
- K023189 — VISTA BASIC WITH FM SYSTEM
- K020785 — INTROCAN SAFETY IV CATHETER
- K022575 — PERFUSOR COMPACT WITH FM SYSTEM
- K022019 — PERIFIX CATHETER CONNECTOR
- K021488 — SURECAN SAFETY HUBER NEEDLE INFUSION SETS
- K021094 — INTROCAN SAFETY IV CATHETER
- K013610 — PERIFIX SAFETY EPIDURAL NEEDLES
- K011975 — HORIZON OUTLOOK WITH DOSECOM
- K003029 — INFUSOMAT P
- K994375 — HORIZON LIGHT
Data sourced from openFDA. This site is unofficial and independent of the FDA.