FDA Device recall Z-2640-2020
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral tr…
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral tr… by Ehob, citing QC inspection observed that a portion of the lot may have been contaminated with blood.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2640-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-09 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ehob |
| Distribution | US |
Product
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.
Reason
QC inspection observed that a portion of the lot may have been contaminated with blood.
Identifiers
| code_info | Lot 93649FA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2020%22
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