Recalls

  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific recalls carotid stents over manufacturing defect

    The FDA said the defect could injure blood vessels, damage the stent or release debris that could travel to the brain and cause a stroke.

    By • Aug. 25, 2025
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    Alamy
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    Medtronic recall of heart vent catheters tied to 3 serious injuries

    The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”

    By • Aug. 19, 2025
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
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    Courtesy of Draeger
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    Draeger removes ventilation filters over misleading carbon dioxide readings

    Hospitals are being advised to stop using the filters after serious injuries were reported related to the problem, the FDA said in a recall notice.

    By • Aug. 12, 2025
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    Courtesy of Boston Scientific
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    Boston Scientific updates instructions of devices linked to 17 deaths

    The update covers devices used in procedures to implant the company’s Watchman heart device.

    By • Aug. 8, 2025
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    Alamy
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    Boston Scientific tells users about defibrillator problem linked to deaths, injuries

    A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

    By • Aug. 7, 2025
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    Courtesy of Tandem Diabetes Care
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    Tandem insulin pump malfunction linked to 59 injuries

     A problem with speakers in Tandem’s t:slim X2 insulin pumps can cause insulin delivery to stop, the company said.

    By • Aug. 7, 2025
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    Patrik Stollarz / Staff via Getty Images
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    Philips BiPAP machine recall associated with 8 deaths

    Philips sent updated instructions after disclosing problems last year with an alarm that can interrupt treatment for people with obstructive sleep apnea or respiratory insufficiency.

    By • Aug. 5, 2025
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    Courtesy of Johnson & Johnson
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    J&J’s Ethicon recalls stapler cartridges over issue linked to 1 death

    The FDA said the device can lock, leading to adverse events including surgical delay, bleeding and death.

    By • Updated July 29, 2025
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    Alamy
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    Edwards recalls arterial cannulas over exposed wires

    Exposed wires could puncture the artery and cause bleeding, inadequate perfusion and hemolysis, the FDA said in its Class I recall notice.

    By • July 25, 2025
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    Sascha Schuermann via Getty Images
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    Baxter recalls certain Novum pumps over issues tied to 79 injuries, 2 deaths

    The company has advised users to change the pump and infusion set at a time when a delay in treatment would not harm the patient.

    By • July 23, 2025
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    Integra recalls cranial drills over defect linked to 10 injuries

    The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA said.

    By • July 17, 2025
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    Courtesy of Abiomed
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    J&J’s Abiomed recalls heart pump controllers after 3 patients die

    The FDA published an early alert, which the agency reserves for potentially high-risk issues.

    By • Updated July 8, 2025
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    Sarah Silbiger via Getty Images
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    Cook Medical recalls catheters over fault linked to 3 serious injuries

    The company began the recall after receiving four field complaints about tip separation before and during use.

    By • June 27, 2025
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    Courtesy of Medtronic
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    Medtronic recall of capsule delivery devices tied to 33 serious injuries

    The Food and Drug Administration published an early alert for the recall on Tuesday. No deaths have been associated with the problem.

    By • June 25, 2025
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    Stringer via Getty Images
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    GE Healthcare recalls Carestation devices over ventilation failure risk

    The recall affects 15 Carestation models and more than 14,000 individual devices.

    By • June 24, 2025
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    Stock via Getty Images
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    Q’Apel recalls clot removal device in response to FDA warning letter

    Rather than pursuing a new regulatory pathway, Q'Apel said it is discontinuing the recalled system “as part of its strategic shift toward newer technologies.”

    By • June 18, 2025
  • A black, rectangular device displays a blood glucose reading, while a white patch that says Dexcom One+ is to the right.
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    Courtesy of Dexcom
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    Dexcom recalls more than 700,000 CGM receivers for lack of audible alarm

    Severe adverse events, including seizure and loss of consciousness, were potentially linked to the issue, based on 56 reports Dexcom received.

    By • Updated June 24, 2025
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    Sarah Silbiger via Getty Images
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    Zyno recalls infusion pumps over unvalidated software

    Customers have been asked to stop using the pumps and wait for someone to contact them about exchanging devices.

    By • June 17, 2025
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    Sarah Silbiger via Getty Images
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    Centerline recalls guidewire over risk of coating being left in patients

    Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures. No serious injuries or deaths have been tied to the recall.

    By • June 16, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic recalls ventilators linked to 2 serious injuries, 1 death

    The recall comes more than one year after Medtronic announced it would exit the ventilator market.

    By • June 12, 2025
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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    Baxter recalls Novum pump linked to 1 serious injury

    The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

    By • Updated June 11, 2025
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic removes tracheostomy tubes due to dislodging risk

    If the tube moves out of place, it could prevent a patient from breathing or block the airway. A Medtronic spokesperson said patient harm was reported in some cases.

    By • June 6, 2025
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    Sarah Silbiger via Getty Images
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    Smiths Medical recalls infusion pumps over 3 problems

    Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm. 

    By • June 4, 2025
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    BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death

    A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.

    By • May 27, 2025
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    HHS overhaul

    RFK’s FDA layoffs could slow safety communications, experts warn

    The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

    By • May 6, 2025