Devices & Diagnostics

The complicated news on device recalls

There were only 167 device recalls in the third quarter, which is down 39 percent from the previous quarter and the lowest it’s been since the fourth quarter of 2011.


Stericycle Expert Solutions just released their Recall Index for the third quarter, and it contains a wealth of information on consumer product, food, pharmaceutical, automobile and medical device recalls. Stericycle crunches data from several federal agencies, such as FDA and USDA, to get these numbers.

But statistics can be like a misdirection play: the ball appears to be moving in one direction, but ultimately is going somewhere else. Stericycle’s Q3 device recall data has a lot of nuance, but overall, it’s good news.

There were only 167 device recalls in Q3, which is down 39 percent from the previous quarter and the lowest it’s been since the fourth quarter of 2011. On the other hand, the number of actual units being recalled went up 1 percent to 68 million. The average recall size was 407,000 units. This actually looks okay with a little context.

“There’s a bit more to the story,” said Chris Harvey, director of Recall Solutions, in a phone interview. “There was one recall that had 54 million units. If you take out that one, the average is around 83,000 per recall.”

That particular recall concerned sterile needles. As a result, sterility issues caused the most recalled units. That outlier highlights some of the difficult decisions device manufacturers must make. Smaller runs could mitigate the risk of an enormous recall but would also increase costs.

“They mass produce these units, like needles and catheters,” said Harvey, “but no company really wants to plan for a recall. Sterility is one of those issues that comes up. Maybe you can reduce the impact by reducing the batch sizes, but you’re not going to completely prevent sterility issues.”

However, setting aside the total number of units being recalled, and focusing on the types of problems, software was predominant, accounting for 24.6 percent of recalls.

“That’s been the same for the past six quarters,” said Harvey. “The more complicated these devices become, the more software, the more opportunity for issues. That’s why software is such a top contributor.”

Some of the problems may stem from the hyper-competitive marketplace – there’s always a rush to get products out. Companies are responding by hiring consultants to assist with cybersecurity and other software issues.

“They really need to focus on minimizing the glitches in software,” said Harvey, “not only for data security issues but just generally to reduce some of the bugs.”

The good news is that the total number of medical device recalls may be trending down. In recent years, the average has been around 1,000 per year. The total for 2016 was around 1,100.

“Through Q3, it’s 726, so we trend that at about 968,” said Harvey. “So slight decrease in medical device recalls.”