FDAClass IIMarch 26, 2025

Diagnostic Neuro IR Tray recall

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

Why was Diagnostic Neuro IR Tray 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00191072212900 00191072218001 Lots 960241 71-050727 71-051234 71-051771 71-052322 71-052501 71-052705

Product
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Recalling firm
American Contract Systems Inc
Quantity
170 kits
Distribution
US Nationwide distribution in the state of OH.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls