E.M Adams co, inc. 26-0692Recalls & reported problems

E.M. Adams, Inc. · LIMB HOLDER · Class 1

Data updated Oct 18, 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 10840200304242), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

Unintended Extubation1

Recent adverse event reports

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

MalfunctionFeb 26, 2025
PATIENT WAS ABLE TO BREAK BOTH SOFT WRIST RESTRAINTS AWAY FROM THE BED AND SELF EXTUBATED DESPITE INTERVENTIONS OF BEDSIDE RN AND RESPIRATORY THERAPIST.
Patient problems: Unintended Extubation
MAUDE report 21468415 ↗

Device details

UDI-DI	`10840200304242`
Brand	E.M Adams co, inc.
Model	26-0692
Company	E.M. Adams, Inc.
Product code	FMQ · Restraint, Protective
Class	Class 1
FDA submission	K971948
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 31, 2021

Device type (GMDN): Limb/torso/head restraint, reusable

A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

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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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