MicroMedical 36-SST1250Recalls & reported problems

Jaeger Medical GmbH · Adult One Way Mouthpiece · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34250892901993), received between Nov 8, 2018 and Nov 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 8, 2018Break; Break
THE CUSTOMER REPORTED THAT THE PLASTIC END PIECE OF MOUTH GUARDS, USED FOR SPIROMETRY, CAME OFF IN THE PATIENT'S MOUTH. THE CUSTOMER WAS UNAWARE IF THE PATIENT BIT DOWN WITH THEIR TEETH, THUS DISLODGING IT. THE CUSTOMER TESTED OTHER MOUTH GUARDS AND FOUND THEM TO BE LOOSE. THE CUSTOMER REPORTED THAT THEIR WAS NO HARM TO THE PATIENT ASSOCIATED WITH THE PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8052942 ↗

Device details

UDI-DI	`34250892901993`
Brand	MicroMedical
Model	36-SST1250
Company	Jaeger Medical GmbH
Product code	BYP · Mouthpiece, Breathing
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 28, 2025

Device type (GMDN): Breathing mouthpiece, single-use

A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.

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All Mouthpiece, Breathing devices →

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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