CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Tensive Conductive Adhesive Gel recalled by Natus Neurology
Natus Neurology is recalling Tensive Conductive Adhesive Gel, distributed nationwide in the US. The recall was initiated on 7 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1305-2024
- FDA event ID
- 93969
- Recalling firm
- Natus Neurology, Middleton, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2024
- FDA classified
- 19 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Feb 2024 | Recall initiated by company | |
| 19 Mar 2024 | Classified by FDA | +41 days |
| 27 Mar 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
TENSIVE Conductive Adhesive Gel, REF 016-401600
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00855683006333, Lot Numbers: A0623009
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93969| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sleep Supplies Start Kit with Single Use Supplies recalled | Natus Neurology | Other | Nationwide |
More recalls from Natus Neurology
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Natus Brain Monitor Breakout recalled by Natus Neurology | Natus Neurology | Device Malfunction | 7 states |
| Device | CLASS II | OBM00002 OBM DAB (Digital Acquisition Box) recalled by Natus Neurology | Natus Neurology | Device Malfunction | Nationwide |
| Device | CLASS II | Sleep Supplies Start Kit with Single Use Supplies recalled | Natus Neurology | Other | Nationwide |
| Device | CLASS II | Ipela Fhd Ptz Tile Kits with Axis cameras used recalled | Natus Neurology | Device Malfunction | Nationwide |
| Device | CLASS II | natus newborn care Olympic Brainz Monitor recalled by Natus Neurology | Natus Neurology | Other | Nationwide |
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