Natus Neurology Inc

Complete recall history across all FDA and CPSC categories — 8 total recalls

Natus Neurology Inc 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 (8)

FDA medical device enforcement actions by Natus Neurology Inc

Date Product Reason Class
Feb 7, 2024 natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla ... Natus has become aware that its third-party supplier Parker Laboratories Inc.... Class II
Feb 7, 2024 TENSIVE Conductive Adhesive Gel, REF 016-401600 Natus has become aware that its third-party supplier Parker Laboratories Inc.... Class II
Feb 1, 2018 Nicolet¿ Ambulatory EEG Potential to be able to import an ambulatory exam for a patient for which the... Class II
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhi... Class II
Jun 9, 2017 Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. ... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhi... Class II
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog C... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhi... Class II
Jun 9, 2017 Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Inten... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhi... Class II
Sep 11, 2015 NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d... When using the NicoletOne v5.94 software, after exiting the impedance check f... Class II

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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