Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IsoGel AIR 84 Recalled by Stryker Medical Division of Stryker Corporation Due to Complaints were received from the field indicating that...

Date: July 12, 2013
Company: Stryker Medical Division of Stryker Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Medical Division of Stryker Corporation directly.

Affected Products

IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.

Quantity: 586 units

Why Was This Recalled?

Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation has 79 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report