How to Monitor Medical Device Recalls and Drug Recalls

The Food and Drug Administration (FDA) publishes all medical device recalls and drug recalls on their web site. In order to search out a specific product under recall, you will need to know the manufacturing firm, as all searches are keyed off of the firm name. It should be noted that in some cases, drugs or medical devices may be manufactured by one firm under license of another firm. In those instances, the company marketing the product is responsible, and will be the firm of record on the FDA site.

In addition, the FDA publishes a weekly report on Wednesdays called the Enforcement Report, listing all recall activities for the prior week. You can register to receive an e-mailed copy of this report. Note that the Enforcement Report covers the entire jurisdiction of the FDA, so it will include food recalls, blood bank issues, as well as medical device and pharmaceutical actions.

The FDA web site will list the recalling firm, a description of the product under recall, catalog and lot numbers being recalled, and a description of the recall. It will also list the quantity recalled and the scope of distribution (what countries the product was distributed too). However, the site will not list clinical implications of the recalled product, so it will not provide the consumer any expectation of what impact the recalled product might have on patients. For that information, you will have to consult a medical professional.

While you may try to contact the manufacturer of a recalled product, chances are they will not discuss medical implications of their recalled product. Manufacturers are not licensed health care providers, and are legally constrained from providing medical advice to patients. While they can and will advise doctors on the intended use of their products, they cannot get between that doctor-patient relationship. Manufacturers are not necessarily trying to obscure issues with patients, despite the frustration you may feel in getting answers.

In the end, to understand how a recalled medical device or drug could impact your life your best bet is consulting your doctor. Securing a lawyer can be helpful, but is not always an automatic step. Only a doctor can assess the potential for harm, and as we will see in the next post, most recalls involve very limited risk to patients.

Leave a Reply