Recalls


  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images

    FDA Class I recalls hit 15-year high in 2022

    The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.

    By March 3, 2023
  • Image of Medtronic's Harmony TPV
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    Courtesy of U.S. Food and Drug Administration

    Medtronic relaunches pulmonary valve that was subject of recall

    Designed to treat a congenital heart defect, the device was launched two years ago, but was recalled after a year.

    By Feb. 23, 2023
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images

    Philips executives waive bonuses after year of recalls; ex-CEO gets $222,000

    The waived incentives coincide with an FDA notice about the recall of some reworked ventilators that Philips initiated late last year.

    By Feb. 22, 2023
  • GE's NM/CT 870 CZT nuclear imaging device
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    Courtesy of GE HealthCare

    GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued

    GE HealthCare has told customers to stop using the machines until company technicians can inspect them and replace dangerous parts. 

    By Feb. 17, 2023
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    Courtesy of Philips

    82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346

    The rate of death reports per month has risen consistently since Philips began the recall in the summer of 2021.

    By Feb. 10, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images

    Medtronic recalls 22,000 hemodialysis catheters for potential hub defect

    The FDA reported two injuries tied to the problem, which could cause leaks across the tubes of the implanted catheters and produce blood clots.

    By Jan. 30, 2023
  • Elements of LivaNova’s LifeSPARC circulatory support system
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    Courtesy of https://www.livanova.com/advanced-circulatory-support/en-us

    LivaNova recalls circulatory support device for software fix

    The update is intended to fix a malfunction that could cause its LifeSPARC pump to stop working. 

    By Jan. 30, 2023
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images

    Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4

    New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”

    By Jan. 30, 2023
  • A Medtronic HVAD pump in the palm of a human hand
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    Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299

    Medtronic asks HVAD users to return batteries with welding defects

    The recall is one of several related to battery issues after the heart pump was pulled from the market.

    By Jan. 23, 2023
  • A physician holding and endoscope
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    Olena Yakobchuk via Getty Images

    Olympus gets two FDA warning letters over safety of reprocessed endoscopes

    The regulator said the companies didn’t adequately test the device assembly process and waited too long to report problems from complaints.

    By Jan. 12, 2023
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    Courtesy of Philips

    Philips’ studies argue recalled DreamStation CPAP machines unlikely to harm patients’ health

    In a briefing on testing of the machines, Philips said exposure to degraded foam used to soundproof the devices is unlikely to harm patients.

    By Dec. 21, 2022
  • Team of surgeons operating on patient in hospital - stock photo Four doctors in hospital operating room with patient lying on operating table. Surgical lights shining on medical team performing operat
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    Johnny Greig via Getty Images

    The 10 biggest medtech stories of 2022

    MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

    By MedTech Dive staff • Dec. 3, 2022
  • A Medtronic HVAD pump in the palm of a human hand
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    Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299

    Medtronic’s HVAD system recalled again amid driveline cover problems

    New issues have continued to surface with the problem-plagued device even after Medtronic pulled it from the market last year.

    By Dec. 1, 2022
  • Philips CPAP machine
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    N/A via Getty Images

    Philips respirator recall reaches 260 reported deaths, FDA says

    The agency has received 90,000 medical device reports related to foam problems with Philips’ recalled sleep apnea devices and ventilators.

    By Updated Nov. 23, 2022
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images

    Philips’ ventilator woes grow as FDA issues alert over replacement foam

    Replacement noise reduction material in Trilogy ventilators can block the air inlet and let trace amounts of particulate matter into the air pathway.

    By Nov. 18, 2022