The Recall Desk
HighFDA (Devices)·Z-2640-2020·Announced 2020-07-29

EHOB Expansion Control Overlay Recalled for Potential Blood Contamination

EHOB, Inc. is recalling 173 Expansion Control Overlays (Item No. 1004EC) because a portion of the lot may have been contaminated with blood.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential blood contamination hazard in a medical device, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

EHOB, Inc. is recalling 173 units of the Expansion Control Overlay, Item No. 1004EC, distributed nationwide in the United States. The recall is limited to Lot 93649FA.

The recall was initiated after quality control inspections observed that a portion of the lot may have been contaminated with blood. The product is a medical device designed to assist in lateral transfers, boosts, and turns to protect patients and relieve pressure at bony prominences.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the contamination.

The recalled product

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 desig
Manufacturer
EHOB, Inc.
Affected units
173

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 93649FA

Distribution

Distributed nationwide across the United States.