FDA Device recall Z-2213-2021
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
- FDA Device
- Class II
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999 by Stryker Medical Division, citing medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2213-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-12 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
Product
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Reason
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Identifiers
| code_info | Serial Numbers: 031528600216109 051428600212599 081328600206460 UDI: 07613327298512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2213-2021%22
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