FDA Medical Device Recalls (openFDA)
EHOB, Inc.: 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.
- Recall number
- Z-2640-2020
- Recalling firm
- EHOB, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-06-09
- Posted
- not on file
- Terminated
- 2021-01-25
- Reason
- QC inspection observed that a portion of the lot may have been contaminated with blood.
- Root cause
- Process control
- Action
- On June 9, 2020, the firm notified affected customers through VOLUNTARY MEDICAL DEVICE RECALL letters. Customers were advised that the affected lot of product may have been exposed to dried bodily fluids. Customers were instructed to not remove unused product from their boxes, nor to open sealed plastic bags that the products are contained in. The product is to be returned to the EHOB Indianapolis Distribution enter. Please contact the firm's Customer Service department at customerservice@ehob.com or (317) 972-4600 to arrange free return shipment. For additional information regarding this notice, you may contact Aaron Kadel, Vice President Engineering and Quality at (800) 899-5553; Monday Friday 9 AM 4 PM EST.
- Quantity
- 173
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot 93649FA
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMP
- Firm FEI
- 1832066
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28