Hill-Rom PRO+ Pressure Relief Mattress Service Correction Reassessment
Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall with no reported injuries or illnesses. Service record inconsistencies are being addressed through preventive reassessment rather than confirmation of an actual defect causing harm, meeting the threshold for Moderate severity.
Plain-English summary
Baxter Healthcare Corporation is issuing a recall notice for 232 Hill-Rom PRO+ 36" MRS Surface mattresses (Model REF P7924A03, UDI/DI 00887761977884). These pressure relief mattresses are intended for patient support and for the prevention and/or treatment of pressure injuries.
Inconsistencies were identified in service records related to a previous Baxter correction notice (reference FA-2022-026). The affected mattresses have been identified as potentially impacted by these service record inconsistencies. Baxter has determined that the mattresses must be reassessed to confirm they have been corrected per the original service order and to verify correct serial numbers have been identified.
The affected units were distributed to Colorado. If you have received any mattresses with the listed serial numbers, contact Baxter Healthcare Corporation for further guidance.
The recalled product
- Product
- Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 232
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/DI 00887761977884
- Serial Numbers: W330BP6363
- W333BP6439
- W334BP6477
- W334BP6535
- W337BP6631
- W341BP6675
- X047BP7353
- X049BP7431
- W330BP6365
- W333BP6440
- W334BP6478
- W334BP6536
- W337BP6632
- W341BP6676
- X047BP7354
- X049BP7432
- W330BP6366
- W333BP6442
- W334BP6480
Distribution
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