Recall Z-1468-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1468-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-25

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-02-25. It names one FDA 510(k) clearance: K122473. 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.. Reason: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-02-25
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-Rom·cleared 2013-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.