In the interest of increased consumer awareness, the U.S. Food and Drug Administration (FDA) recently announced that the agency will be posting device recall information on its website more quickly than it did in previous years.
Previously, the FDA would post device recall information only after the agency announced the affected company’s initiation of a correction or removal action. But now, the FDA plans to post information on the Center for Devices and Radiological Health’s (CDRH) Medical Device Recalls Database at the time the company takes the action and notifies the FDA that it can post the information, not at the time of the FDA’s recall classification.
Recent Medical Device Recalls
The FDA issued 39 device recalls in 2016, the last for an orthopedic device used during hip replacement surgeries – Greatbatch Medical’s recall of its Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. The recall was initiated because non-sterile surgical devices may lead to infections, serious health consequences, and even death.
Thirty-two recalls were issued in 2015, down from 60 in 2014, and so far in 2017 there have been three medical device recalls:
• Bard Peripheral Vascular Inc. recalled the Halo One Thin-Walled Guiding Sheath due to sheath separation, kinking or tip damage.
• bioMerieux recalled the NucliSENS easyMAG Magnetic Silica and SucliSENS Magnetic Extraction Reagents due to inaccurate test results.
• Nurse Assist Inc. recalled the company’s Normal Saline Flush IV Syringes due to possible Burkholderia cepacia (B. cepacia) bloodstream infections.
The FDA has said the process and timelines for reporting a correction or removal of a device will not change, and the agency may also post company press releases or other public notices about recalls, market withdrawals, and safety alerts that may potentially present significant risks to consumers of the product.
