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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Baxter Healthcare Corporation: Centrella Bed Mattresses Recalled for Mattress Cover Delamination

Agency Publication Date: June 14, 2024
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Summary

Baxter Healthcare Corporation is recalling approximately 38,136 Centrella Max and Pro+ hospital bed mattress surfaces and over 20,000 service parts. The top cover of these mattresses can delaminate—meaning the layers of the fabric separate—due to improper cleaning or the use of bleach-based cleaners without adequate instructions. This defect was identified following reports that the cleaning protocols did not provide enough detail on how to safely use bleach without damaging the material. Consumers should check their specific mattress model and contact Baxter for updated cleaning instructions or assistance.

Risk

When the mattress cover delaminates, it can compromise the fluid barrier of the bed. This could allow bodily fluids or cleaning chemicals to penetrate the inner foam of the mattress, potentially leading to cross-contamination between patients or exposure to hazardous materials.

What You Should Do

  1. Identify if your hospital bed uses an affected surface by checking the REF (Reference) and UDI-DI numbers on the product label. Affected models include Centrella Max Surface (P7922A01, P7922A02, P7922A03, P7922ARENT01), Centrella Pro+ Surface (P7923A01, P7923A02, P7923A03, P7923A04, P7924A01, P7924A02, P7924A03, P7924A04, P7924ARENT01), and Pro+ MRS Surfaces (P006800A01, P006800A03, P3255A01, P3255A02, P3255ARENT01).
  2. Inspect the top covers of all identified mattresses for signs of delamination, such as bubbling, peeling, or separation of the fabric layers.
  3. Review the cleaning and disinfection protocols currently in use at your facility to ensure they align with the most recent safety communications regarding bleach concentrations.
  4. Contact Baxter Healthcare Corporation at their Deerfield, Illinois headquarters or through their customer service channels to receive the updated cleaning and maintenance instructions for these specific mattress surfaces.
  5. If you are a healthcare provider, consult with your medical device safety officer regarding the continued use of any mattresses showing visible damage or delamination.
  6. For additional questions or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Updated cleaning instructions and manufacturer consultation.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centrella Max Surface
Model / REF:
P7922A01
P7922A02
P7922A03
P7922ARENT01
Lot Numbers:
UDI-DI 887761999084
UDI-DI 887761999077
UDI-DI 887761984639
UDI-DI 887761976962
Product: Centrella Pro+ Surface
Model / REF:
P7923A01
P7923A02
P7923A03
P7923A04
Lot Numbers:
UDI-DI 887761977945
UDI-DI 887761977938
UDI-DI 887761977921
UDI-DI 887761977914
Product: Pro+ MRS Surface for Hillrom 900 / Versacare
Model / REF:
P006800A01
P006800A03
P3255A01
P3255A02
P3255ARENT01
Lot Numbers:
UDI-DI 887761977846
UDI-DI 887761955035
UDI-DI 887761977860
UDI-DI 887761977853
UDI-DI 887761976887
Product: Pro+ MRS Surface (Various sizes)
Model / REF:
P7924A01
P7924A02
P7924A03
P7924A04
P7924ARENT01
Lot Numbers:
UDI-DI 887761977907
UDI-DI 887761977891
UDI-DI 887761977884
UDI-DI 887761977877
UDI-DI 887761976863

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94600
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Government distribution; Military distribution; Direct sales to healthcare facilities
Manufactured In: United States
Units Affected: 38,136 mattress units and 20,187 service part units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.