FDA Device recall Z-1946-2013

IsoGel AIR 84, Support Surface

FDA Device
Class II
terminated
Published 2013-08-21

On 2013-08-21 the FDA classified a Class II recall of IsoGel AIR 84, Support Surface by Stryker Medical Division, citing 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 settin….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1946-2013
Classification	Class II
Status	terminated
Initiated	2013-07-12
Published	2013-08-21
Last updated	2026-09-13 11:53 UTC
Company	Stryker Medical Division
Distribution	US

Product

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

Reason

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

Identifiers

code_info	Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121… 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, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 121228600200402, 121228600200403, 121228600200404, 121228600200405, 011328600100406 011328600100412, 011328600100413, 011328600100414, 011328600100415, 011328600100416 011328600100422, 011328600100423, 011328600100424, 011328600100425, 011328600100426 011328600100432, 011328600100433, 011328600100434, 011328600100435, 011328600100436

code_info

Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121…

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, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 121228600200402, 121228600200403, 121228600200404, 121228600200405, 011328600100406 011328600100412, 011328600100413, 011328600100414, 011328600100415, 011328600100416 011328600100422, 011328600100423, 011328600100424, 011328600100425, 011328600100426 011328600100432, 011328600100433, 011328600100434, 011328600100435, 011328600100436

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1946-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.