The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1411-2022·Announced 2022-07-27

Medical Device Recall: Hill-Rom PRO+ Mattress Microclimate Feature Failure

Hill-Rom PRO+ mattresses are being recalled for a Microclimate Management feature failure that could increase pressure ulcer risk in patients. The recall affects 200 units distributed in the US and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall affecting vulnerable hospital patients. No reported illnesses or injuries, but the device failure reduces the microclimate management feature's performance, increasing the risk of pressure ulcer development.

Plain-English summary

The Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress (REF P7924A01 and P7924ARENT01) is subject to a recall due to a device failure that affects its Microclimate Management feature.

This feature is designed to pull heat and moisture away from the patient to help prevent pressure ulcers. When the failure occurs, the feature's performance can be reduced, potentially increasing the patient's risk of pressure ulcer development.

Approximately 200 affected mattresses have been distributed worldwide, including across multiple US states (Arizona, California, Colorado, Connecticut, Georgia, Iowa, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, South Dakota, Tennessee, Texas, Vermont, and Wisconsin) and in Canada. Specific serial numbers of affected units are available from the manufacturer.

Healthcare facilities using any of the affected mattresses should contact Baxter Healthcare Corporation, the manufacturer, to address the failure mode and arrange for inspection, repair, or replacement of the affected devices.

The recalled product

Product
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Hospital Mattress System
Hazard
Affected units
200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF P7924A01
  • UDI 00887761977907
  • Serial numbers: W218BP4042
  • W218BP4054
  • W218BP4056
  • W218BP4059
  • W218BP4060
  • W218BP4061
  • W218BP4058
  • W218BP4048
  • W218BP4069
  • W218BP4053
  • W218BP4041
  • W218BP4043
  • W218BP4044
  • W218BP4045
  • W218BP4046
  • W218BP4049
  • W218BP4051
  • W218BP4052

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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