NeoSeal® MicroRecalls & reported problems
Neotech Products LLC · The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10812594012164), received between Aug 18, 2023 and Jul 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond3
Patient problems
- Cough2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
INFANT INGESTED ONE OF THESE ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613245 ↗InjurySep 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
AN INFANT IN THE NICU WAS REPORTED BY THE PARENT TO HAVE COUGHED UP A PIECE OF NEOSEAL.
Patient problems: Cough
MAUDE report 17830541 ↗InjuryAug 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
A 42 WEEK INFANT WHO WAS ADMITTED TO NICU FOLLOWING BIRTH NEEDING RESPIRATORY SUPPORT VIA NASAL CANNULA. NEOTECH FOAM BARRIER IN PLACE. INFANT FOUND TO BE DESATURATING AND CHOKING ON FOAM BARRIER. ONCE RN REMOVED FOAM BARRIER INFANT RECOVERED IMMEDIATELY. FOAM BARRIERS REMOVED FROM UNIT.
Patient problems: Cough
MAUDE report 17575314 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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