1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Recalls

Q1 Recalls Snapshot: It’s A Mixed Bag As Device Recalls Fall 10% But Recalled Units Rise 3%

 
• By Shawn M. Schmitt

Recalls initiated by the medical device industry were relatively stable in the first quarter of 2021 as companies recalled 212 products, a 10% decrease from the previous quarter. Check out our Q1 recalls infographic for more.

Q1 Device Recalls

Medical device recalls were relatively stable in the first quarter of 2021. Manufacturers recalled 212 products, a noteworthy 10% drop from Q4 2020, when there were 235 corrections and removals. Meanwhile, the number of recalled units increased slightly in Q1, to 60,768,817. That’s 3% higher than in Q4, when 59,314,216 units were recalled, and marks the most units recalled since Q1 2020. In announcing its most recent quarterly recalls index, Sedgwick Brand Protection noted that one recall of gowns accounted for 29 million of the recalled units.

Informa Pharma Intelligence

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
Start Free Trial

Already a subscriber?

More from Recalls

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

 
• By Brian Bossetta

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

 
• By Brian Bossetta

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

 
• By Brian Bossetta

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

 
• By Sarah Karlin-Smith

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

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

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

 
• By Brian Bossetta

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.