Z-1457-2020Class II

Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and...

Name: Z-1457-2020 Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and...
Creator: EHOB, Inc.
Published: 2020-01-19
License: https://open.fda.gov/license/

EHOB, Inc. / initiated 2020-01-19 / Terminated / root cause: manufacturing process

FDA source

EHOB, Inc. began a recall of Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE... on 2020-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1457-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-19
Posted: 2020-03-09
Terminated: 2020-08-05
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.
Product code: IKY Mattress, Flotation Therapy, Non-Powered
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] 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 in commerce: U.S. (TX)
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: Master Lot # 932213A, Product Lot Code 932243A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1457-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09

Product code IKY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)