Bio-Logic Algo Supplies 011445Recalls & reported problems
Natus Medical Incorporated · Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used with Natus hearing screeners. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830001885), received between Jun 1, 2022 and Feb 20, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Component or Accessory Incompatibility1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Rash1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility
PART 011445 FLEXICOUPLER AND JELLY TAB COMBO PACK - THE CUSTOMER REPORTED: THE EARMUFFS THAT WE USE FOR THE HEARING SCREEN, THE STICKY PART IS EXTREMELY STICKY AND IS VERY DIFFICULT TO GET OFF THE PATIENT. WE USED WET WIPES TO HELP TAKE IT OFF FROM THE SKIN. PATIENT HAD A RED RING AROUND HIS RIGHT EAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18740621 ↗MalfunctionJun 1, 2022Melted; Melted
PART 040546 SUPPLIES PACK, ALGO. THE GEL PART OF A JELLY TUB SENSOR KIT HAD MELTED, AND WHEN THESE WERE USED TO EXAMINE NEWBORNS, THE SKIN OF THE NEWBORNS DEVELOPED A RED RASH.
Patient problems: Rash
MAUDE report 14567373 ↗
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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
- 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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