CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare
Baxter Healthcare is recalling Pro+ Mrs Surface For Versacare, mattress with Advanced Microclimate Technology (Amt) uses, distributed nationwide in the US. The recall was initiated on 18 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3262-2026
- FDA event ID
- 99606
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2026
- FDA classified
- 24 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Aug 2026 | Recall initiated by company | |
| 24 Sep 2026 | Classified by FDA | +37 days |
| 30 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PRO+ MRS SURFACE FOR VERSACARE, 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: P3255A08
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99606This product is part of a recall event; the main page for the event is PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |