APEXRecalls & reported problems across all models
B. Braun Medical Inc. · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 287
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 17 models of APEX by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 287 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Sep 21, 2026 — classified as 287 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (220 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported APEX problems
Device problems
- Contamination /Decontamination Problem220
- Application Program Problem: Dose Calculation Error27
- Failure to Align18
- Device Contamination with Chemical or Other Material7
- Improper Flow or Infusion7
- Thermal Decomposition of Device4
- Contamination of Device Ingredient or Reagent3
- Device Alarm System3
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- No Patient Involvement134
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient7
- Electrolyte Imbalance1
APEX models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- APEX™ 2112531CONTAINER, I.V.69 reports
- APEX™ 2112530CONTAINER, I.V.66 reports
- APEX™ AX1000SYSTEM/DEVICE, PHARMACY COMPOUNDING47 reports
- APEX™ 2112532CONTAINER, I.V.35 reports
- APEX™ 2112529CONTAINER, I.V.31 reports
- APEX™ 2112528CONTAINER, I.V.16 reports
- APEX™ 601220SYSTEM/DEVICE, PHARMACY COMPOUNDING5 reports
- APEX™ 601223SYSTEM/DEVICE, PHARMACY COMPOUNDING5 reports
- APEX® 601237System/device, pharmacy compounding2 reports
- APEX™ 2112534CONTAINER, I.V.2 reports
- APEX™ 2112541Set, i.V. Fluid transfer2 reports
- APEX™ 601224SYSTEM/DEVICE, PHARMACY COMPOUNDING2 reports
- APEX® 601238System/device, pharmacy compounding1 report
- APEX™ 2112533CONTAINER, I.V.1 report
- APEX™ 2112535CONTAINER, I.V.1 report
- APEX™ 2112536CONTAINER, I.V.1 report
- APEX™ 2112540Set, i.V. Fluid transfer1 report
Recent APEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Application Program Problem: Dose Calculation Error
As reported by the user facility: Several source containers running dry during dispense.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840785 ↗MalfunctionJul 7, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 UNIT WAS IDENTIFIED TO HAVE PARTICULATE MATTER - MOBILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736954 ↗MalfunctionJul 7, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: ONE UNIT FROM THIS LOT WAS ORIGINALLY REJECTED ON NOV 07, 2025 FOR PARTICULATE MATTER IN SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25736953 ↗MalfunctionJul 1, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DESCRIPTION PARTICULATE MATTER IDENTIFIED DURING INCOMING AQL INSPECTION OF RECEIVED QUANTITY OF APEX SINGLE CHAMBER BAG 250 ML LOT 25C22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676811 ↗MalfunctionJun 19, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: I HAVE 1 APEX EVA MIXING CONTAINER 3 LITER BAG AND IT HAS A WHITE FOREIGN MATTER INSIDE THE BAG AND I WOULD LIKE TO REPORT THAT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563841 ↗MalfunctionJun 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - MOBILE WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375862 ↗MalfunctionMay 18, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - EMBEDDED WAS LOCATED, CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200361 ↗MalfunctionMay 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SOME OF THESE UNITS WERE USED IN PRODUCTION AND FOUND TO HAVE 1 PARTICULATE MATTER - SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25141637 ↗MalfunctionApr 22, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DURING RAW MATERIAL INSPECTION, 1 PARTICULATE MATTER - MOBILE WAS LOCATED CAUSING A FAILURE OF RAW MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953950 ↗MalfunctionApr 22, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTING UPON OPENING THE FIRST BAG OF A 5 PACK THEY NOTICED ONE OF THE PORT CAPS HAS A BROWN SPOT THAT LOOKS LIKE A SMALL WORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953888 ↗MalfunctionApr 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 500ML FINAL CONTAINERS DIRTY ADD PORTS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851654 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A HAIR WAS FOUND INSIDE A SEALED APEX CONTAINER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844062 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: 3L FINAL CONTAINER PLASTIC PARTICLE IN PACKAGING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843833 ↗MalfunctionApr 10, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A HAIR WAS FOUND INSIDE A SEALED APEX CONTAINER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839098 ↗MalfunctionApr 6, 2026Labelling, Instructions for Use or Training Problem
AS REPORTED BY THE USER FACILITY: THE OUTER BOX IS LABELED 500 ML BUT INSIDE THE OVERWRAP IS LABELED 1000ML AND ACTUALLY IS 500 ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793126 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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