SafeDAYRecalls & reported problems across all models

We found 10 models of SafeDAY by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and May 11, 2026 — classified as 108 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (59 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

SafeDAY 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-0712-2026 · Root cause: Process control · Recall details · FDA record ↗

2. 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-0711-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported SafeDAY problems

SafeDAY models

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

• SafeDAY™ 352635

  Set, administration, intravascular
  1 recall2 reports
• SafeDAY™ 352646

  Stopcock, i.V. Set
  1 recall2 reports
• SafeDAY™ 352894

  Set, administration, intravascular
  34 reports
• SafeDAY™ 352904

  Set, administration, intravascular
  15 reports
• SafeDAY™ 352900

  Set, administration, intravascular
  14 reports
• SafeDAY™ 415108

  Set, administration, intravascular
  12 reports
• SafeDAY™ 352901

  Set, administration, intravascular
  11 reports
• SafeDAY™ 362006

  Set, administration, intravascular
  8 reports
• SafeDAY™ 352899

  Set, administration, intravascular
  6 reports
• SafeDAY™ 352905

  Set, administration, intravascular
  4 reports

Recent SafeDAY adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: UPON OPENING ITEM # 352635, FOREIGN OBJECTS WERE FOUND INSIDE THE FLUID CHAMBER OF THIS 60-DROP IV ADMINISTRATION SET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135642 ↗
• MalfunctionFeb 23, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: AIR IN TUBING LINE. THE END USER WAS EVALUATING THIS IV EXTENSION SET DESIGN AND REPORTED THAT AIR IS ENTERING THE LINE AT THE STOPCOCK. INITIALLY, THEY BELIEVED THE ISSUE WAS RELATED TO THE DUST COVER ON THE STOPCOCK, SINCE THEIR CURRENT BAXTER SET USES A LUER ATTACHMENT AND DOES NOT PRESENT THIS PROBLEM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413273 ↗
• MalfunctionOct 11, 2024Leak/Splash; Leak/Splash

  AS REPORTED, EVENT 3 RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905 LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427362 ↗
• MalfunctionOct 11, 2024Leak/Splash; Leak/Splash

  AS REPORTED, EVENT 2: RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905, LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427309 ↗
• MalfunctionOct 11, 2024Leak/Splash; Leak/Splash

  AS REPORTED, EVENT 1: RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905 LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427291 ↗
• MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: PRODUCT CONCERN CUSTOMER STATED: THE PRODUCT HAS A SAFETY ISSUE TOO MUCH AIR TO THE PATIENT HAD TO DISCONNECT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083933 ↗
• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE LAD SAFEDAY BLUE NEEDLES CONNECTOR DETACHED FROM THE EXTENSION SET AND SPILLED BLOOD AND RADIOPHARMACEUTICAL CONTAMINANT ALL OVER. DRUG USED WAS MYOVIEW: TECHNETIUM TC99M TETROFOSMIN INJECTION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559066 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY. DESCRIPTION: WHEN IT WAS ATTACHED TO THE IV CATHETER, IT WOULD LEAK BLOOD AT THE BASE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520231 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION: WHEN IT WAS ATTACHED TO THE IV CATHETER, IT WOULD LEAK BLOOD AT THE BASE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520226 ↗
• MalfunctionFeb 24, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION IT WAS REPORTED THAT BLOOD LEAKED DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595800 ↗
• MalfunctionDec 27, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET HAS A DIRTY CHAMBER. THERE IS BROWN RUST COLORED DIRT INSIDE OF THE CHAMBER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090734 ↗
• MalfunctionMar 19, 2021Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY: THE NURSE IS EXPERIENCING AIR IN LINE ALARMS ON THE VISTA PUMP WHEN ADMINISTERING IVIG IN GLASS BOTTLE VIA TUBING 352894. THIS DOES NOT HAPPEN WITH FLUIDS IN SOFT IV CONTAINERS. THE SOLUTION IS NOT COLD WHEN ADMINISTERED. THE TUBING IS VENTED. SHE SOMETIMES SEES SMALL BUBBLES. SHE GETS ALARMS WHEN THIS OCCURS AND SHE RESOLVES BY OPENING THE DOOR AND CLEARING THE TUBING OF THE BUBBLES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526987 ↗
• MalfunctionFeb 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  EVENT 2: AS REPORTED BY THE USER FACILITY: A SET WAS LEAKING WHILE THE ROLLER CLAMP AND SLIDE CLAMP ABOVE THE FILTER WERE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314311 ↗
• MalfunctionFeb 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  EVENT 1: AS REPORTED BY THE USER FACILITY: A SET WAS LEAKING WHILE THE ROLLER CLAMP AND SLIDE CLAMP ABOVE THE FILTER WERE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314307 ↗
• MalfunctionDec 16, 2020Free or Unrestricted Flow; Infusion or Flow Problem; Free or Unrestricted Flow; Infusion or Flow Problem

  EVENT 3: AS REPORTED BY THE USER FACILITY: "WE HAVE NOTICED THAT THE FILTERED TUBING WE HAVE BEEN USING IS LEAKING AT THE END PORT BETWEEN TWO OF THE PLASTIC PIECES. THIS IS HAPPENING EVEN WHEN THE ROLLER CLAMP AND THE SLIDE CLAMP ARE CLOSED. EVEN WHEN BOTH CLAMPS ARE CLOSED, THE TUBING STILL LEAKS, AND IF THE END OF THE TUBING IS RAISED ABOVE THE BAG, AIR FLOWS INTO THE END OF THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021289 ↗

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