PlainRecalls
FDA Devices Moderate Class II Ongoing

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1354-2025

Product Description

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

Reason for Recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Details

Units Affected
170 kits
Distribution
US Nationwide distribution in the state of OH.
Location
Tiffin, OH

Frequently Asked Questions

What product was recalled?
DIAGNOSTIC NEURO IR TRAY , Model No WENE21. Recalled by American Contract Systems Inc. Units affected: 170 kits.
Why was this product recalled?
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1354-2025.