Natus Medical Incorporated

Complete recall history across all FDA and CPSC categories — 18 total recalls

Natus Medical Incorporated appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Natus Medical Incorporated

Date Product Reason Class
Nov 28, 2023 External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due t... Class II
Nov 28, 2023 EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Sterility assurance cannot be guaranteed for external drainage systems due t... Class II
Nov 18, 2022 The Natus Cranial Access Kit is designed to be a complete, single use and dis... Due to Cranial Access Kits containing recalled sterile surgical drapes. The ... Class II
May 22, 2017 The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for ... Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully... Class II
Apr 3, 2017 Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 200... The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2... Class II
Oct 28, 2016 Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to... neoBLUE blanket LED Phototherapy System distributed since release of the prod... Class II
Sep 16, 2016 Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides photothe... The firm sent the Technical Bulletin to consignees who received the reliabili... Class II
Aug 25, 2016 The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item n... NatalCare LX incubators may have a defective base where the weld holding the ... Class II
Apr 22, 2016 Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filte... The replacement HEPA Filters have been manufactured with sealant that may not... Class II
Apr 11, 2016 Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assemb... The firm is adding the warning statement to the Instruction for Use for the n... Class II
Jan 8, 2016 Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. NatalCare LX Incubators were manufactured using a defective oval port hinge a... Class II
Aug 5, 2015 Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part ... The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 w... Class II
Mar 16, 2015 Natus neoBLUE blanket LED Phototherapy system which includes the following it... neoBLUE blanket LED Phototherapy System is recalled because Natus has receive... Class II
Jan 2, 2015 EPWorks software used in the Xltek Protektor Stimulator Product Usage: In... Software error occurs when using remote monitoring; if the remote user tries ... Class II
Jan 2, 2015 EPWorks software used in the Protektor 32 Product Usage: Uses electroence... Software error occurs when using remote monitoring; if the remote user tries ... Class II
Nov 19, 2014 Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLU... Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed a... Class II
May 21, 2012 Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... Olympic Cool-Cap Cooling Module's power supply failed during treatment. The ... Class II
May 9, 2012 The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... The Olympic Cool-Cap's Control Module has experienced a frozen screen during ... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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