The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1416-2022·Announced 2022-07-27

Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance

Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.

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: This is an FDA Class II recall for a risk-of-harm product (hospital mattress with patient safety implications). Although no illnesses or injuries have been reported, the failure mode creates increased risk of pressure ulcer development, a serious patient care concern. The theoretical hazard without reported injuries places this at Score 3 per the rubric.

Plain-English summary

Hill-Rom Centrella Pro+ 36-inch surface mattresses (REF P7923A03) with certain serial numbers are being recalled due to a failure in the Microclimate Management feature.

The affected mattresses may experience reduced performance in the system that pulls heat and moisture away from the patient. This malfunction increases the risk of pressure ulcer development in patients using these mattresses.

The recalled units were distributed nationwide in the United States (including 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), as well as Canada. Government facilities received affected units, but military facilities did not.

Patients and healthcare facilities should verify their mattress serial number against the provided list. If your mattress is affected, contact the manufacturer or healthcare provider for repair or replacement options.

The recalled product

Product
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Hospital Mattress
Hazard
Affected units
70

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)

  • UDI 00887761977921
  • Serial numbers: W217BP4016
  • W217BP4039
  • W217BP4040
  • W228BP4177
  • W228BP4179
  • W228BP4180
  • W228BP4189
  • W228BP4190
  • W228BP4193
  • W228BP4194
  • W228BP4195
  • W228BP4198
  • W228BP4199
  • W228BP4201
  • W217BP4014
  • W217BP4015
  • W217BP4018
  • W217BP4019
  • W217BP4024

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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