Medline DYND300040SRecalls & reported problems
Medline Industries, Inc. · SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277699526), received between Jun 3, 2019 and Dec 31, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Inflation Problem1
- Material Too Rigid or Stiff1
- Positioning Problem1
- Unintended Deflation1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, THE ANESTHESIA TEAM REPORTED THAT THE BALLOON IS NOT STAYING INFLATED LEADING TO "SEVERAL" INCIDENTS WHERE THE TUBE REQUIRED REINSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933986 ↗MalfunctionDec 30, 2025Unintended Deflation; Unintended Deflation
ACCORDING TO THE CUSTOMER, THE ANESTHESIA TEAM REPORTED THAT THE BALLOON IS NOT STAYING INFLATED LEADING TO "SEVERAL" INCIDENTS WHERE THE TUBE REQUIRED REINSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919526 ↗InjuryOct 12, 2022Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
ACCORDING TO THE FACILITY WHEN REPOSITIONING THE PATIENT TO A SITTING POSITION THE LARYNGEAL MASK 'POPS OUT, REQUIRING THE STAFF TO PUSH THE DEVICE BACK IN'.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15587997 ↗InjuryJun 3, 2019Material Too Rigid or Stiff; Positioning Problem
IT WAS REPORTED THAT THE LARYNGEAL MASK AIRWAY'S (LMA) CUFF WAS STIFF RESULTING IN THE LMA NOT SEATING CORRECTLY IN THE PATIENT'S AIRWAY AND THE PATIENT DEVELOPING LARYNGOSPASM.
Patient problems: No Code Available
MAUDE report 8663935 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- GUEDEL AIRWAY, SIZE 2, ISO 8 1112080Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- KING LTS-D Kit KLTSD430King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300040PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- King LTS-D KLTSD422King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- GUEDEL AIRWAY, SIZE 000, ISO 3.5 1000035Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- Medline DYND300020PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300025PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300010PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.