CARESAFERecalls & reported problems across all models

We found 9 models of CARESAFE by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2023 and Feb 20, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

CARESAFE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0623-2026 · Root cause: Process control · names 8 of these models · Recall details · FDA record ↗

Most reported CARESAFE problems

CARESAFE models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CARESAFE™ 354304

  Set, administration, intravascular
  1 recall1 report
• CARESAFE™ 354303

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354305

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354307

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354310

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354302

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354306

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 354308

  Set, administration, intravascular
  1 recall0 reports
• CARESAFE™ 471858

  Set, administration, intravascular
  3 reports

Recent CARESAFE adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE. IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24406323 ↗
• MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24406322 ↗
• MalfunctionFeb 20, 2026Leak/Splash; Reflux within Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE, AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24406318 ↗
• MalfunctionNov 16, 2023Inaccurate Flow Rate; Free or Unrestricted Flow; Inaccurate Flow Rate; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: ROLLER CLAMP IS NOT WORKING PROPERLY. DETAILED INQUIRY DESCRIPTION: WE HAD ISSUES WITH CONTROLLING THE RATE OF FLOW WITH THE ROLLERBALL. IT HAD TO BASICALLY BE CLOSED TO REDUCE THE DRIP RATE MAKING IT DIFFICULT TO TITRATE THE FLOW. MANY PATIENTS RECEIVED ALMOST THE ENTIRE LITER OF FLUID BEFORE REACHING THE OR EVEN WHEN THE NURSES FELT THEY HAD ADEQUATELY CLOSED THE ROLLERBALL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151034 ↗

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