# FDA recall Z-2640-2020

> **EHOB, Inc.** · Class II · device recall initiated 2020-06-09.

## 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 for recall

QC inspection observed that a portion of the lot may have been contaminated with blood.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2640-2020
- **Recalling firm:** EHOB, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-09
- **Report date:** 2020-07-29
- **Termination date:** 2021-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2020

## Citation

> AI Analytics. FDA recall Z-2640-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2640-2020. Source: US FDA. Licensed CC0.

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