Steripath Micro 4005-ENRecalls & reported problems
Magnolia Medical Technologies, Inc. · SteriPath Micro, Luer, 5ml · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858366007412), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion1
- Self-Activation or Keying1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Self-Activation or Keying; Improper Flow or Infusion
STERIPATH HAS A WASTE BUTTON THAT ALLOWS BLOOD TO TRAVEL TO THE WASTE CONTAINER FIRST, THEN TO THE BLOOD TUBE. ON THIS PRODUCT, THE WATER BUTTON HAS ALREADY BEEN PUSHED, MEANING UNWASTED BLOOD WOULD FLOW INTO THE COLLECTION TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436621 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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