B. Braun Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
245 (21 Class I)
510(k) Clearances
2
Inspections
13
Compliance Actions
0

Known Names

b. braun medical, b braun medical

Recent Recalls

NumberClassProductDate
D-0353-2025Class II0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation ConMarch 31, 2025
Z-1021-2025Class IIDesign Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic aDecember 4, 2024
Z-3144-2024Class IIAET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, August 8, 2024
D-0638-2024Class I0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine,July 24, 2024
Z-2381-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for June 17, 2024
Z-2403-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump June 17, 2024
Z-2394-2024Class IIInfusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intraJune 17, 2024
Z-2398-2024Class IIInfusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump June 17, 2024
Z-2399-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump foJune 17, 2024
Z-2397-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pumpJune 17, 2024
Z-2392-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump foJune 17, 2024
Z-2385-2024Class IIInfusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump forJune 17, 2024
Z-2379-2024Class IIInfusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump foJune 17, 2024
Z-2389-2024Class IIInfusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump foJune 17, 2024
Z-2386-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump fJune 17, 2024
Z-2384-2024Class IIInfusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenoJune 17, 2024
Z-2383-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump fJune 17, 2024
Z-2402-2024Class IIOutlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump forJune 17, 2024
Z-2377-2024Class IIOUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (June 17, 2024
Z-2391-2024Class IIInfusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump June 17, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K963440DIALOG DIALYSIS MACHINEJune 26, 1998
K962084OMNICAN SYRINGEFebruary 10, 1997