PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered sys...
FDA Device Recall #Z-3264-2026 - Class II, August 18, 2026
Recall Summary
| Recall Number | Z-3264-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 18, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 6 units |
Product Description
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14
Reason for Recall
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Information
Serial Number: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3263-2026 | Class II | PRO+ 36" MRS SURFACE, mattress with Advanced Mi... | Aug 18, 2026 |
| Z-3262-2026 | Class II | PRO+ MRS SURFACE FOR VERSACARE, mattress with A... | Aug 18, 2026 |
| Z-3066-2026 | Class II | Baxter Novum IQ Syringe Pump, Loaner, Model Num... | Aug 11, 2026 |
| Z-3065-2026 | Class II | Baxter Novum IQ Syringe Pump, Model Number 4080... | Aug 11, 2026 |
| Z-3257-2026 | Class II | Brand Name: VOLARA System Product Name: VOLARA... | Aug 3, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.