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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Cyberonics, Inc

Complete recall history across all FDA and CPSC categories — 9 total recalls

Cyberonics, 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 (9)

FDA medical device enforcement actions by Cyberonics, Inc

Date Product Reason Class
Dec 2, 2017 VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Us... Two Model 3000 Programmers were distributed in error by prior to FDA approval... Class II
Nov 13, 2017 VNS Therapy Programmer, Model 3000, v1.0 System Certain Model 3000 programming events can result in miscalculation of paramet... Class II
Jun 13, 2017 VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... Manufacturing process used to assemble the circuit board may result in some d... Class II
Jun 13, 2017 VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... Manufacturing process used to assemble the circuit board may result in some d... Class II
Dec 18, 2015 VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjuncti... Recall being initiated in response to three reports of "Burst Watchdog Timeou... Class II
Nov 18, 2015 Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use o... Class II
Oct 7, 2015 Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use o... Class II
Mar 6, 2015 VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener... The pulse generators have a lower battery longevity than specified in their d... Class II
Nov 20, 2014 Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Ther... The recalled product was distributed with an incorrect serial number printed ... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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