CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

Nicolet¿ Ambulatory EEG recalled by Natus Neurology

Natus Neurology is recalling Nicolet¿ Ambulatory EEG, distributed in 25 states. The recall was initiated on 1 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00382830043670; Serial Numbers MBR120693, MBR100549, MBR100566, MBR120699, MBR090299, MBR090317, MBR150907, MBR100541, MBR120700, MBR120681, MBR120686, MBR120697, MBR130793, MBR110634, MBR150920, MBR150921, MBR160934, MBR120665, MBR110629, MBR090308, MBR150885, MBR090327, MBR120720, MBR130784, MBR130785, MBR120696, MBR100579, MBR090318, MBR150928, MBR100610, MBR110642, MBR090313, MBR100578, MBR100564, MBR100626, MBR120683, MBR100594, MBR090324, MBR090326, MBR090329, MBR100583, MBR100602, MBR100603, MBR100624, MBR120659, MBR120674, MBR100567, MBR140853, MBR100565, MBR110645, LBR06094, LBR06095, LBR06101, MBR120660, MBR100550, MBR120671, MBR150886, MBR150890, MBR150893, MBR150894, MBR100573, MBR150896, MBR150897, MBR150902, MBR150904, MBR150911, MBR150916, MBR150918, MBR150919, MBR150908, MBR150930, MBR150931, MBR100552, MBR100596, MBR100601, LBR06133, MBR110638, MBR140836, MBR100572, MBR110649, MBR100532, MBR100548, MBR110630, MBR120734, MBR150898, MBR100592, MBR090303, MBR090306, MBR100586, MBR100600, MBR150887, MBR150888, MBR100545, MBR100555, MBR120658, MBR120680, MBR120687, MBR160952, MBR140857, MBR120762, MBR100580, MBR100591, MBR140862, MBR150922, MBR140856, MBR140865, MBR150903, MBR140861, MBR140834, MBR140858, 140859, MBR140863, MBR140864, MBR140866, MBR150884, MBR150917, MBR160936, MBR160941, MBR160962, MBR160969, 80218, LBR120757, LBR120759, LBR120771, MBR110635, MBR110640, MBR110643, MBR110644, MBR110647, MBR120661, MBR120662, MBR120675, MBR120725, MBR120733, MBR140833, MBR140835, MBR140838, MBR100625, MBR150899, MBR110646, MBR150913, MBR090321, MBR090330, MBR100585, MBR100617, MBR110641, MBR120679, MBR120710, MBR120715, MBR120718, MBR120754, MBR120760, MBR120763, MBR130794, MBR140815, MBR150926, LBR06028, LBR06051, MBR100614, MBR100621, MBRL20672, MBR140811, MBR150929, 150923, MBR120653, MBR120713, MBR150925, MBR150891

Quantity recalled171 units

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-2568-2018
FDA event ID: 80023
Recalling firm: Natus Neurology, Middleton, WI
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2018
FDA classified: 28 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Feb 2018	Recall initiated by company
28 Jul 2018	Classified by FDA	+177 days
8 Aug 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

Product as listed by the FDA

Nicolet¿ Ambulatory EEG

Where it was distributed

Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietnam.

Arkansas Arizona California Colorado District of Columbia Florida Georgia Idaho Illinois Indiana Massachusetts Maine Michigan Missouri North Carolina North Dakota New Jersey Nevada New York Pennsylvania

Questions about this recall

Why was it recalled?

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

Which lots are affected?

UDI 00382830043670; Serial Numbers MBR120693, MBR100549, MBR100566, MBR120699, MBR090299, MBR090317, MBR150907, MBR100541, MBR120700, MBR120681, MBR120686, MBR120697, MBR130793, MBR110634, MBR150920, MBR150921, MBR160934, MBR120665, MBR110629, MBR090308, MBR150885, MBR090327, MBR120720, MBR130784, MBR130785, MBR120696, MBR100579, MBR090318, MBR150928, MBR100610, MBR110642, MBR090313, MBR100578, MBR100564, MBR100626, MBR120683, MBR100594, MBR090324, MBR090326, MBR090329, MBR100583, MBR100602, MBR100603, MBR100624, MBR120659, MBR120674, MBR100567, MBR140853, MBR100565, MBR110645, LBR06094, LBR06095, LBR06101, MBR120660, MBR100550, MBR120671, MBR150886, MBR150890, MBR150893, MBR150894, MBR100573, MBR150896, MBR150897, MBR150902, MBR150904, MBR150911, MBR150916, MBR150918, MBR150919, MBR150908, MBR150930, MBR150931, MBR100552, MBR100596, MBR100601, LBR06133, MBR110638, MBR140836, MBR100572, MBR110649, MBR100532, MBR100548, MBR110630, MBR120734, MBR150898, MBR100592, MBR090303, MBR090306, MBR100586, MBR100600, MBR150887, MBR150888, MBR100545, MBR100555, MBR120658, MBR120680, MBR120687, MBR160952, MBR140857, MBR120762, MBR100580, MBR100591, MBR140862, MBR150922, MBR140856, MBR140865, MBR150903, MBR140861, MBR140834, MBR140858, 140859, MBR140863, MBR140864, MBR140866, MBR150884, MBR150917, MBR160936, MBR160941, MBR160962, MBR160969, 80218, LBR120757, LBR120759, LBR120771, MBR110635, MBR110640, MBR110643, MBR110644, MBR110647, MBR120661, MBR120662, MBR120675, MBR120725, MBR120733, MBR140833, MBR140835, MBR140838, MBR100625, MBR150899, MBR110646, MBR150913, MBR090321, MBR090330, MBR100585, MBR100617, MBR110641, MBR120679, MBR120710, MBR120715, MBR120718, MBR120754, MBR120760, MBR120763, MBR130794, MBR140815, MBR150926, LBR06028, LBR06051, MBR100614, MBR100621, MBRL20672, MBR140811, MBR150929, 150923, MBR120653, MBR120713, MBR150925, MBR150891

Where was it sold?

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.

More recalls from Natus Neurology

All 16

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Device	CLASS II	Natus Brain Monitor Breakout recalled by Natus Neurology	Natus Neurology	Device Malfunction	7 states
18 Jun 2025Device	CLASS II	OBM00002 OBM DAB (Digital Acquisition Box) recalled by Natus Neurology	Natus Neurology	Device Malfunction	Nationwide
27 Mar 2024Device	CLASS II	Sleep Supplies Start Kit with Single Use Supplies recalled	Natus Neurology	Other	Nationwide
27 Mar 2024Device	CLASS II	Tensive Conductive Adhesive Gel recalled by Natus Neurology	Natus Neurology	Other	Nationwide
2 Mar 2022Device	CLASS II	Ipela Fhd Ptz Tile Kits with Axis cameras used recalled	Natus Neurology	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide