Arjo Hospital Equipment AB Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Brand
Arjo Hospital Equipment AB
Lot Codes / Batch Numbers
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Products Sold
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Arjo Hospital Equipment AB is recalling Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with due to The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026