Progressa bed surfaces recalled for mattress dips when head elevated
Baxter Healthcare's Progressa Bed Surfaces may develop dips in the mattress when the head of the bed is elevated, as air bladders inside can shift out of position. This could reduce the bed's effectiveness at preventing pressure ulcers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a functional defect that could impact patient safety by reducing pressure relief effectiveness. However, no illnesses or injuries have been reported, making the maximum score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation has recalled Progressa Bed Surfaces, medical devices designed to treat or prevent pulmonary and other complications associated with immobility. The recall affects 2,126 units distributed nationwide in the United States and internationally. The affected product codes are P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress surface. This defect could reduce the bed's ability to evenly distribute pressure and support patients at risk for pressure ulcers and other immobility-related complications.
Patients currently using affected Progressa Bed Surfaces should contact their healthcare provider or Baxter Healthcare Corporation immediately. Users should verify their product code and serial number against the recall list. Healthcare facilities should check their inventory and follow Baxter's instructions for device inspection, replacement, or return.
The recalled product
- Product
- Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Bed Surfaces
- Hazard
- mattress-defect
- pressure-relief-failure
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 (12)
- P7520A19 UDI-DI: 00887761999893
- P7520A20S UDI-DI: 00887761999886
- P7520A21 UDI-DI: 00887761999879
- P7520A22S UDI-DI: 00887761999862
- P7520A23 UDI-DI: 00887761999855
- P7520A24S UDI-DI: 00887761999848
- P7520A3 UDI-DI: 00887761999770
- P7520A31 UDI-DI: 00887761999756
- P7520A37 UDI-DI: 00887761999718
- P7520A39 UDI-DI: 00887761999701
- P7520A45 UDI-DI: 00887761999671
- P7520A4S UDI-DI: 00887761999657
Distribution
Distributed nationwide across the United States.
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