Q4 Recalls Snapshot: Fewer Devices Recalled By Industry, But Software Troubles Still Abound

Problems with software were the No. 1 reason for medical device recalls in the fourth quarter of 2020. Also: Recalls fell by a modest 3%, but the number of recalled device units mushroomed 158%. Check out our Q4 recalls infographic.

Q4 Device Recalls

The number of product recalls initiated by manufacturers fell slightly in the fourth quarter of 2020 – but there was an increase in the count of recalled device units. There were 235 corrections and removals in Q4, compared to 242 in Q3 – a modest 3% decrease. Meanwhile, industry recalled 59,314,216 units in Q4, a 158% increase from Q3, when 22,951,964 units were pulled from the market. In its State of the Nation 2021 recalls index, business solutions company Sedgwick points out that industry is still having troubles with software, as it’s once again the top recall cause – as it has been for 18 of the past 19 quarters.

Nancy Pham / Informa Pharma Intelligence

More from Recalls

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
• By 

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.

Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

More from Policy & Regulation

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.