Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil

FDA device recall Z-1468-2025 · posted 2025-03-26 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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.

Action taken

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 2/25/25 was sent to customers. Actions to be Taken by Customers 1. Please locate all affected units within your facility by reviewing the product label at the head end of the Progressa bed surface with the affected product details provided above. Baxter recommends identifying patients at a higher risk for pressure injuries and placing these patients on alternate beds, if available. 2. A Baxter representative will contact your facility to schedule the correction of your impacted surfaces, or you may contact the Baxter Technical Support Team at 800-445-3720, option 2, between the hours of 8:00 am and 6:00 pm Eastern Time, Monday through Friday. Please work with your Baxter representative to ensure that the affected beds are available for correction (not in use). 3. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply form instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to the Biomedical Engineering Department, and any other departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and ch

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

IOQ

Quantity affected

2,126 units

Distribution

US Nationwide. Global Distribution.

Date initiated

2025-02-25

Date posted

2025-03-26

Location

Deerfield, IL

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