Z-1950-2021Class II

Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of...

Name: Z-1950-2021 Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of...
Creator: EHOB, Inc.
Published: 2021-04-19
License: https://open.fda.gov/license/

EHOB, Inc. / initiated 2021-04-19 / Open, Classified / root cause: manufacturing process

FDA source

EHOB, Inc. began a recall of Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general... on 2021-04-19. FDA classified it as Class II and gives the reason as "Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1950-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-19
Posted: 2021-06-24
Recalling firm: EHOB, Inc.
Product: Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
Product code: IKY Mattress, Flotation Therapy, Non-Powered
Reason for recall: Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
Root cause tag: manufacturing process
FDA root cause: Process control
Action: EHOB issued recall notification Urgent Medical Device Recall letter 0n 4/19/21 via electronically tracked signature documents. The letter states reason for recall, health risk and action to take: Products should not be removed from their box 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 recall notice is temporary, is limited to the identified lot of this product, and does not cause a shortage of availability. Additionally, all other lot numbers of this product are safe for use and available for distribution. 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 .
Quantity in commerce: 70 units
Distribution: US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
Product codes and lots: Lot Number: 105013A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1950-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-30	2021-06-24

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)