Indianapolis, IN, United States
EHOB, Inc. recalls
3 recalls recorded since 2018, most recently on 19 April 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 April 2021
- Reason
- Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
- Distribution
- US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1950-2021
- 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
Terminated Class II Medical devices
- Recall started
- 9 June 2020
- Terminated
- 25 January 2021
- Reason
- QC inspection observed that a portion of the lot may have been contaminated with blood.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2640-2020
- 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. Th
Terminated Class II Medical devices
- Recall started
- 19 January 2020
- Terminated
- 5 August 2020
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1457-2020
- 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 pressu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.