Sleep Supplies Start Kit (Natus) – Adhesive Gel Concern (2024)
This product may cause skin irritation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Brand
Natus Neurology Inc
Lot Codes / Batch Numbers
UDI/DI x, Lot Numbers: 614922, 614923, 614921, 122923, 628166
Products Sold
UDI/DI x, Lot Numbers: 614922, 614923, 614921, 122923, 628166
Natus Neurology Inc is recalling natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, R due to Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.
Recommended Action
Per FDA guidance
Natus issued an Urgent Medical Device Recall Notice to its consignees on 02/07/2024 via UPS and email. The notice explained the issue and risk to health. It also requested the consignee cease use, complete and return the form for the replacement of the product.
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