SafeDAY™ 352635Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET 60 DROP W/2 SAFEDAY · Class 2
All models of SafeDAY (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955594948), received between Feb 23, 2026 and May 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 29, 2025Class IIOpen, 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 problems
Device problems
- Air/Gas in Device1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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