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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
EHOB, Inc.
Lot Codes / Batch Numbers
Lot 93649FA
Products Sold
Lot 93649FA
EHOB, Inc. is recalling Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a s due to QC inspection observed that a portion of the lot may have been contaminated with blood.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
QC inspection observed that a portion of the lot may have been contaminated with blood.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026