Natus Medical recalls

Natus Medical has 17 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 10 Jan 2024. 3 are still ongoing. The most frequent reason is device malfunction.

Total recalls17since 2012

Last 12 months0reported

Class I16% of total

Ongoing3latest 10 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 6%Class II 16 94%Class III 0 0%

Why natus medical is recalled

Product types

By year

2024212%
202216%
2017212%
2016529%
2015424%
201416%
2012212%

Ongoing natus medical recalls

3 active

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS II	External Drainage System Collection recalled	Natus Medical	Sterility	Nationwide
10 Jan 2024Device	CLASS II	EDS 3 CSF External Drainage System recalled	Natus Medical	Sterility	Nationwide
28 Dec 2022Device	CLASS II	The Natus Cranial Access Kit is designed to be a complete recalled	Natus Medical	Sterility	Nationwide

All natus medical recalls, newest first

17 total

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS II	External Drainage System Collection recalled	Natus Medical	Sterility	Nationwide
10 Jan 2024Device	CLASS II	EDS 3 CSF External Drainage System recalled	Natus Medical	Sterility	Nationwide
28 Dec 2022Device	CLASS II	The Natus Cranial Access Kit is designed to be a complete recalled	Natus Medical	Sterility	Nationwide
19 Jul 2017Device	CLASS II	The Olympic Pasteurmatic recalled by Natus Medical Incorporated	Natus Medical	Other	Nationwide
10 May 2017Device	CLASS II	Second generation neoBLUE LED Phototherapy Light recalled	Natus Medical	Other	Nationwide
21 Dec 2016Device	CLASS II	Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy recalled	Natus Medical	Potency & Assay	Nationwide
21 Dec 2016Device	CLASS II	Updated Natus neoBLUE blanket LED Phototherapy Systems recalled	Natus Medical	Device Malfunction	Nationwide
19 Oct 2016Device	CLASS II	The Medix NatalCare LX Intensive Care Incubator recalled	Natus Medical	Device Malfunction	15 states
8 Jun 2016Device	CLASS II	Replacement HEPA filter for Natus Sterile-Drier recalled	Natus Medical	Sterility	18 states
20 Apr 2016Device	CLASS II	Medix NatalCare St-lx Intensive Care Incubator recalled	Natus Medical	Device Malfunction	Nationwide
28 Oct 2015Device	CLASS II	Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy recalled	Natus Medical	Other	Nationwide
22 Apr 2015Device	CLASS II	Natus neoBLUE blanket LED Phototherapy system recalled	Natus Medical	Device Malfunction	WA
18 Feb 2015Device	CLASS II	EPWorks software used in the Xltek Protektor Stimulator Product recalled	Natus Medical	Device Malfunction	Nationwide
18 Feb 2015Device	CLASS II	EPWorks software used in the Protektor 32 Product Usage: Uses recalled	Natus Medical	Device Malfunction	Nationwide
31 Dec 2014Device	CLASS II	Replacement LED PCB Kit recalled by Natus Medical Incorporated	Natus Medical	Other	WA
12 Dec 2012Device	CLASS I	The product products recalled by Natus Medical Incorporated	Natus Medical	Device Malfunction	Nationwide
27 Jun 2012Device	CLASS II	Olympic Cool-Cap System is intended to provide treatment recalled	Natus Medical	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.