FDA Device recall Z-1950-2021
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sore…
- FDA Device
- Class II
- ongoing
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sore… by Ehob, citing product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1950-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-19 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ehob |
| Distribution | US |
Product
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
Reason
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
Identifiers
| code_info | Lot Number: 105013A |
|---|
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-1950-2021%22
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