The manufacturing, repackaging, re-labeling and importation of medical devices is regulated by the Center for Devices and Radiological Health (CDRH), a department of the Federal Food and Drug Administration (FDA). All medical devices sold in the United States are classified according to the level of precision required to operate the device safely and effectively. Reports on devices which have malfunctioned or caused death or serious injury are collected by the CDRH and stored in the Medical Device Reporting (MDR) database and the Manufacturer and User Facility Device Experience (MAUDE) database.
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• Cardiac Science Defibrillator Recall
• Composix Kugel Hernia Mesh Patch
• CT Scan Radiation
• Custom Cranial Implants
• DePuy Hip Replacement Recall
• DePuy LPS Diaphyseal Sleeve Recall
• DES – Drug Eluting Stents
• Ear Candles
• Gadolinium & Nephrogenic Systemic Fibrosis (NSF)
• Guidant Defibrillator
• Hip and Knee Prostheses
• Hemostasis Valves – Guardian II and Gaurdian II NC
• Insulin Pump Recalls
• IVC Filters
• Lumenis VersaCut Tissue Morcellator Recall
• Medtronic Defibrillator
• Medtronic Defibrillator Lead
• Medtronic Infuse Bone Graft
• Nobel Biocare NobelDirect Dental Implant
• Vaginal Mesh
• Zimmer Durom Cup
• St. Jude Medical Riata Lead
Medical Devices and Products Recalls
At least weekly the Food and Drug Administration (FDA) issues health warnings and recall notices to the public. A recall is a method of removing or correcting medical products that are in violation of laws administered by the FDA. Recall is a generally voluntary action that takes place because medical device manufacturers and distributors carry out their responsibility to protect the public health and well being from products that present a risk of injury or gross deception or are otherwise defective. The agency provides guidance so that responsible companies may conduct an effective recall.
A recall is an alternative to an FDA-initiated court action for removing or correcting defective medical products that have been distributed. The FDA has established specific recall procedures for o monitor recalls and to assess the adequacy of a company’s efforts in recall. Voluntary recalls may occur at any time by manufacturers and distributors. In some instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, the FDA may issue a recall order to the manufacturer. A request by the FDA that a company recall a product is reserved for urgent situations and is directed to the company that has primary responsibility for the manufacture and marketing of the product that is to be recalled.
A recall does not include market withdrawal or a stock recovery. A market withdrawal is a company’s removal or correction of a distributed product that involves a minor violation that would not be subject to legal action by the FDA or which involves no violation. However, under a specific FDA code, Medical Device Correction and Removals, manufacturers (including re-furbishers and re-conditioners) and importers are required to make a report to the FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.
The following are some frequently used terms regarding medical device recalls:
Correction means repair, modification, adjustment, re-labeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.
Market withdrawal means a company’s removal or correction of a distributed product that involves a minor violation that would not be subject to legal action by the FDA or which involves no violation.
Recall means a company’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action such as seizure. Recall does not include a market withdrawal or a stock recovery.