Agency classClass IIOur severity:High FDA (Devices)·Z-2213-2021·Announced 2021-08-18

Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities

Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.

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: FDA Class II medical device intended for healthcare professional use was distributed to home users lacking professional training. No illnesses or injuries have been reported, but this is a risk-of-harm product where improper use in a non-clinical setting could lead to inadequate care.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the IsoGel Air support surface, Model Number 2860 (Part 2860000999). This medical device is designed to assist in the prevention and treatment of pressure ulcers and is intended exclusively for use in healthcare facilities by trained professionals.

According to the FDA, the manufacturer distributed 3 units to residential customers who may be using the device in home environments. While the product labeling correctly identifies the appropriate use environment, home users may not be aware of or fully understand the specialized instructions provided for healthcare professionals.

The affected devices were distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The specific serial numbers and UDI identifier for the recalled units are documented in the FDA recall database.

The recalled product

Product: IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Pressure Ulcer Support Surface
Hazard: improper-use
untrained-users
Affected units: 3

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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