Stryker IsoAir 2.0 Support Surface Recalled for CPR Connector Defect
Stryker is recalling 110 IsoAir 2.0 support surfaces because a connector defect may delay CPR during cardiac arrest.
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 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a delay in resuscitation during cardiac arrest, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 110 units of the Stryker IsoAir 2.0 support surface, Model Number 2941-001-100. The product is intended to provide pressure redistribution and assist in managing the microclimate of patient skin.
The recall is due to a defect where the connector between the support surface and the pump may be out of tolerance. This issue can result in difficulty removing the CPR connector, which may cause a delay in resuscitation efforts for patients experiencing cardiac arrest who need CPR.
The affected units were distributed nationwide in the United States, including in California, Florida, New York, and Ohio. Healthcare facilities and consumers should check their serial numbers against the list provided by the FDA and contact Stryker for instructions on how to proceed.
The recalled product
- Product
- Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Support Surface
- Affected units
- 110
Distribution
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