Z-2640-2020Class II

Expansion Control Overlay, Item No. 1004EC -

Name: Z-2640-2020 Expansion Control Overlay, Item No. 1004EC -
Creator: EHOB, Inc.
Published: 2020-06-09
License: https://open.fda.gov/license/

EHOB, Inc. / initiated 2020-06-09 / Terminated / root cause: manufacturing process

FDA source

EHOB, Inc. began a recall of Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and... on 2020-06-09. FDA classified it as Class II and gives the reason as "QC inspection observed that a portion of the lot may have been contaminated with blood". 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-2640-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-09
Posted: 2020-07-20
Terminated: 2021-01-25
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.
Product code: FMP Protector, Skin Pressure
Reason for recall: QC inspection observed that a portion of the lot may have been contaminated with blood.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 173
Distribution: US Nationwide distribution.
Product codes and lots: Lot 93649FA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2640-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2640-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-17

Product code FMP

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)