Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
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: This is a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is precautionary in nature—potential delamination and fluid ingress—with no actual incidents documented.
Plain-English summary
Baxter Healthcare Corporation is recalling Hill-Rom pro+ mattresses due to potential delamination of the mattress cover. Multiple product codes and serial numbers are affected, including models 20877002S, 20877003S, 20877004S, 20877007S, 20877008S, 21649301S, 21649401S, 21649402S, P006800A01, P006800A02, P3255A01, P3255A02, P3255A03, P3255ARENT01, P7923A01, P7923A02, P7923A03, P7923A04, P7924A01, P7924A02, P7924A03, P7924A04, and P7924ARENT01.
The issue involves potential damage to the mattress cover (delamination) which may allow fluids to be absorbed into the mattress. This fluid ingress could compromise device integrity and may create hygiene concerns in healthcare settings.
The affected mattresses were distributed worldwide, including throughout the United States and in Canada and Qatar. Approximately 5,549 units are involved in this recall. Healthcare facilities and consumers with these mattresses should contact Baxter Healthcare Corporation for instructions regarding the recalled products.
No illnesses or injuries related to this issue have been reported to date.
The recalled product
- Product
- Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q)…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 5,549
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)
- a) 20877002S
- UDI/DI N/A
- Serial Numbers: W315BP5905
- W315BP5907
- W315BP5910
- W315BP5911
- b) 20877003S
- Serial Numbers: W301BP5612
- W301BP5615
- c) 20877004S
- Serial Numbers: W231BP4205
- W238BP4341
- W238BP4342
- W238BP4343
- W238BP4345
- W238BP4347
- W238BP4348
- W238BP4349
- W246BP4519
- W246BP4525
Distribution
Distributed nationwide across the United States.
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