FDA Medical Device Recalls (openFDA)
EHOB, Inc.: Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
- Recall number
- Z-1457-2020
- Recalling firm
- EHOB, Inc.
- Product
- Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
- Status
- Terminated
- Initiated
- 2020-01-19
- Posted
- not on file
- Terminated
- 2020-08-05
- Reason
- Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
- Root cause
- Material/Component Contamination
- Action
- EHOB, Inc. issued a "Voluntary Medical Device Recall" letter dated January 19, 2020 via email. Letter provides identification of the issue, health risk and action to take. Distributor was advised that the products have the potential to expose patients, health care providers, or other persons when handling them unpackaged, to dried bodily fluids and told products should not be removed from their boxes as they are packaged in an arrangement to eliminate exposure via individually sealed plastic bag containers inside the corrugate box. Do not open the sealed plastic bags that the products are contained in. This product is to be returned to the EHOB Indianapolis Distribution Center at the address listed below. Please contact our 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. Medical Device Recall Return Response provided with letter - Response is required.
- Quantity
- U.S. (TX)
- Distribution
- US Nationwide distribution in the state of TX.
- Lot, serial or model codes
- Master Lot # 932213A, Product Lot Code 932243A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKY
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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