FDA Device recall Z-2211-2021
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710,…
- FDA Device
- Class II
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710,… 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-2211-2021 |
| 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
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
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: 111427102713678 UDI:N/A |
|---|
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-2211-2021%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.