The Recall Desk
ModerateFDA (Devices)·Z-1946-2013·Announced 2013-08-21

Stryker Recalls IsoGel AIR 84 Support Surfaces Due to Air Pump Alarm Issues

Stryker is recalling 586 IsoGel AIR 84 support surfaces because connected air pumps may flash and alarm due to pressure blockages.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses or injuries, and the defect involves a functional alarm and pressure blockage rather than a direct physical hazard like fire or sharp edges, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 586 units of the IsoGel AIR 84 Support Surface. The product is intended to assist in improving human patient outcomes. The recall covers model numbers 2860-000-001 and 2860-000-002, with specific serial numbers listed in the official notice.

The recall was initiated after complaints indicated that some Air Pumps flashed and alarmed when connected to the IsoGel AIR surface and set to IsoGel AIR Mode. Investigation determined that the flashing and alarming were caused by air pressure falling outside the expected range, indicating a blockage within the LAL tubing. The affected units were distributed nationwide in the United States, including the states of Ohio, Maine, Illinois, Colorado, Florida, Texas, Michigan, Georgia, and Virginia.

Healthcare facilities and consumers should stop using the affected IsoGel AIR 84 support surfaces and contact Stryker for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Affected units
586

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355
  • 121228600100356
  • 121228600100357
  • 121228600200315
  • 121228600200316 121228600200322
  • 121228600200323
  • 121228600200324
  • 121228600200325
  • 121228600200326 121228600200332
  • 121228600200333
  • 121228600200334
  • 121228600200335
  • 121228600200336 121228600200342
  • 121228600200343
  • 121228600200344
  • 121228600200345
  • 121228600200346 121228600200352
  • 121228600200353
  • 121228600200367
  • 121228600200368

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically: