NA Table Pad (REF BF016)Recalls & reported problems

Steris Corporation · The 2-inch PRS Tabletop Pad Set is used with the STERIS 5085 Harmony General Surgical Table. · Class 1

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 00724995156596), received between May 28, 2025 and May 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

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

Most reported problems

Device problems

Detachment of Device or Device Component1

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.

MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THE TABLETOP PAD SETS TO THEIR 5095 SURGICAL TABLES WERE NOT STAYING IN PLACE WHEN THE PATIENT WAS IN TRENDELENBURG. IN ONE OF THE PROCEDURES, THERE WAS A REPORT OF DELAY DUE TO THE PATIENT BEING REPOSITIONED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100842 ↗

Device details

UDI-DI	`00724995156596`
Brand	NA
Model	Table Pad
Catalog no.	BF016
Company	Steris Corporation
Product code	LWG · SURGICAL TABLE CUSHION
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 12, 2021

Device type (GMDN): Operating table mattress, basic

A foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.