PlainRecalls

Natus Medical Incorporated

Compiled from official public sources by the editorial team.

18 recalls on record · Latest: Jan 10, 2024

Natus Medical Incorporated Recall Insight

Natus Medical Incorporated appears on 18 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.018% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jan 10, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 18 entries, severity tagging shows 1 critical, 17 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 18 of 18 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (18). The date window on this page runs from Jun 27, 2012 to Jan 10, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jan 10, 2024

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

FDA Devices Moderate Jan 10, 2024

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

FDA Devices Moderate Dec 28, 2022

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intr…

FDA Devices Moderate Jul 19, 2017

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthes…

FDA Devices Moderate May 10, 2017

Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 0409…

FDA Devices Moderate Dec 21, 2016

Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radi…

FDA Devices Moderate Dec 21, 2016

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE bl…

FDA Devices Moderate Oct 19, 2016

The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.

FDA Devices Moderate Jun 22, 2016

Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758,…

FDA Devices Moderate Jun 8, 2016

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

FDA Devices Moderate Apr 20, 2016

Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

FDA Devices Moderate Oct 28, 2015

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

FDA Devices Moderate Apr 22, 2015

Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blank…

FDA Devices Moderate Feb 18, 2015

EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and tr…

FDA Devices Moderate Feb 18, 2015

EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal cond…

FDA Devices Moderate Dec 31, 2014

Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

FDA Devices Critical Dec 12, 2012

The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic ence…

FDA Devices Moderate Jun 27, 2012

Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use …

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.