Q1 Recalls Snapshot: Recalled Units Skyrocket 457%; Largest Quarterly Number In 13 Years

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Q1 written on a speechbubble

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, consulting firm Stericycle said in its most recent recalls index. There were 343 recall events initiated in Q1, a 126% increase over Q4 2017, when there were 152. Q1 2018 had the largest number of recall events in a given quarter since Stericycle began tracking medical device recalls 13 years ago. Moreover, the number of recalled device units also skyrocketed, from 37.4 million in Q4 '17 to 208.4 million in Q1 '18 – an increase of 457%. Stericycle, which gathered its recalls data from FDA Enforcement Reports, noted that the number of Q1 recalled units was more than all of 2017's recalled units combined (182.2 million). Troubles with software, mislabeling and quality were the top 3 causes of recall events in Q1 2018 – the same as in Q4 2017.

From the editors of The Gray Sheet

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

More from Policy & Regulation

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Global Medtech Guidance Tracker: May 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By 

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?