Expansion Control Overlay — Class II medical device recall Z-2640-2020
Terminated recall by EHOB, Inc., reported 2020-07-29, distributed nationwide. QC inspection observed that a portion of the lot may have been contaminated with blood.
| Recall number | Z-2640-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EHOB, Inc., Indianapolis, IN, United States |
| Recall initiated | 2020-06-09 |
| Classified | 2020-07-17 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 173 |
| Lot numbers | 93649FA |
| Model numbers | 1004EC |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2640-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.