IsoGel AIR 84 — Class II medical device recall Z-1946-2013
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2013-08-21, distributed nationwide. Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connect
| Recall number | Z-1946-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2013-07-12 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 586 units |
| Serial numbers | 011328600100406, 011328600100407, 011328600100408, 011328600100409, 011328600100410, 011328600100411, 011328600100412, 011328600100413, 011328600100414, 011328600100415, 011328600100416, 011328600100417, 011328600100418, 011328600100419, 011328600100420, 011328600100421, 011328600100422, 011328600100423, 011328600100424, 011328600100425, 011328600100426, 011328600100427, 011328600100428, 011328600100429, 011328600100430 and 475 more |
| Model numbers | 2860-000-001, 2860-000-002 |
Product
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1946-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.