Medline NON081343Recalls & reported problems

Medline Industries, Inc. · PAD,ARMBOARD,CONV,FOAM,2X8X20",12PR/CS · 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 10884389122273), received between Sep 21, 2026 and Sep 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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

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

Most reported problems

Device problems

Failure to Unfold or Unwrap1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 21, 2026Failure to Unfold or Unwrap
It was reported that when they open them, they are deformed and do not inflate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843078 ↗

Device details

UDI-DI	`10884389122273`
Brand	Medline
Model	NON081343
Company	Medline Industries, Inc.
Product code	CCX · SUPPORT, PATIENT POSITION
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 23, 2023

Device type (GMDN): Freestanding patient positioner, single-use

A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Other SUPPORT, PATIENT POSITION devices

ALLEN 103001
Hill-Rom, Inc. · SUPPORT, PATIENT POSITION
1 recall17 reports
DeRoyal 8000HDP
Deroyal Industries, Inc. · SUPPORT, PATIENT POSITION
16 reports
PILLOW, GENTLETOUCH, 7 INCH RT 1937
Mizuho Orthopedic Systems, Inc. · Support, Patient Position
11 reports
Battalion 27428
Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION
3 reports
ACUFEX 72205103
Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION
2 reports
Medline MSC50023
Medline Industries, Inc. · SUPPORT, PATIENT POSITION
2 reports
MEDLINE NON081147
Medline Industries, Inc. · SUPPORT, PATIENT POSITION
2 reports
Olympic Vac-Pac Size 30
Natus Medical Incorporated · Support, Patient Position
2 reports

All SUPPORT, PATIENT POSITION 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page