Recall Register

Natus Medical Incorporated: FDA recalls

FDA enforcement reports name Natus Medical Incorporated as the recalling firm in 16 events. The events have 18 product records. The recalls started from 2012 to 2023. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

16 events, newest first.

FDA enforcement events of Natus Medical Incorporated
InitiatedProduct (first record)TypeClassRecordsStatus
28 Nov 2023External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx onlyDeviceClass II2Ongoing
18 Nov 2022The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised…DeviceClass II1Ongoing
22 May 2017The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW…DeviceClass II1Terminated
3 Apr 2017Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.DeviceClass II1Terminated
28 Oct 2016Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299…DeviceClass II1Terminated
16 Sep 2016Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to…DeviceClass II1Terminated
25 Aug 2016The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.DeviceClass II1Terminated
22 Apr 2016Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.DeviceClass II1Terminated
11 Apr 2016Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemiaDeviceClass II1Terminated
8 Jan 2016Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.DeviceClass II1Terminated
5 Aug 2015Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103DeviceClass II1Terminated
16 Mar 2015Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with…DeviceClass II1Terminated
2 Jan 2015EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patient’s neurological status during…DeviceClass II2Terminated
19 Nov 2014Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.DeviceClass II1Terminated
21 May 2012Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic…DeviceClass II1Terminated
9 May 2012The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored…DeviceClass I1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Natus Medical Incorporated: events for each product type
TypeEvents
Device16
Natus Medical Incorporated: events in each class
ClassEvents
Class II15
Class I1
Share of the events of the firm in Class I
6%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Natus Medical Incorporated, by the year that the recall started. The largest year is 2016, with 6 events.

Official channels

Cite this page

Recall Register. Natus Medical Incorporated: FDA recalls. https://recallregister.com/firm/natus-medical-incorporated/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
WA, CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Natus Medical Incorporated have?
Class II: 15 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Natus Medical Incorporated?
FDA event 93550, which the firm started on 28 Nov 2023. The first product in the record is: External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
How many FDA recalls of Natus Medical Incorporated have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.