Regulatory Focus™ > News Articles > Massive Recall of Medical Devices Largest Ever Recorded by FDA

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Posted 02 September 2014 | By Alexander Gaffney, RAC

Massive Recall of Medical Devices Largest Ever Recorded by FDA


A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA.

Background: Recall Trends

The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification—FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

FDA Medical Device Recalls by Date

According to FDA data, the agency typically recalls between 13 and 75 devices each day, though the overwhelming majority of those recalls are either Class II or Class III recalls, which reflect lesser (and non-deadly) safety risks than Class I. Since 2004, 86% of all recalls have been Class II recalls, while 7% have been Class III and 6% have been Class I.

But with the exception of a few outliers, such as the November 2012 recall of 146 devices (of which all but six were Class II) and the April 2014 recall of 119 devices (of which all but one were Class II), FDA has seen relatively few major device recall events, even as the overall number of device recall events has dramatically surged since June 2012.

Massive Recall

But on 29 August 2014, FDA posted to its website 233 Class I recalls, all for devices manufactured by Customed.

From the voluntary recall notices posted to FDA's website, all of the devices were recalled for a single reason: Packaging flaws.

"Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots)," FDA explained in the notice. "This could result in an injury to the patient due to product contamination or loss of sterility condition."

In a warning to healthcare providers on 26 August 2014, FDA said that at least one of the devices was being recalled due to "adhesion" in the sterile packaging. "The defect could result in loss of product sterility and lead to infection."


ref="">confirmed in a statement that all recalled devices were being recalled due to sterility concerns. No serious injuries or deaths have yet been reported to FDA, the agency said. The recall of the devices was reportedly initiated in June 2014 via an email and letter to all affected customers.

Several hundred thousand units are likely affected by the recall, according to data provided on FDA's website.

In addition to being the largest FDA recall on record, it is also most than 9 times larger than the previous largest Class I recall of devices—the 5 March 2014 recall of 28 devices—according to FDA data. Device Recalls Page

Recall Event

Customed Inc Release


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