Recalls
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FDA expands early alert program to cover all medical devices
After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.
By Nick Paul Taylor • Sept. 30, 2025 -
Courtesy of Abiomed
J&J’s Abiomed starts third heart pump controller recall since June
As of Aug. 27, the company had reported five serious injuries and no deaths associated with the issue.
By Nick Paul Taylor • Sept. 24, 2025 -
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TrendlineMedical 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 -
Sarah Silbiger via Getty Images
Olympus removes needles after patient death
Olympus is recalling certain lots of needles, used for lung cancer biopsy, because components can detach during procedures.
By Elise Reuter • Updated an hour ago -
Sasirin Pamai via Getty Images
Exactech agrees to $8M settlement over defective knee implants
The payment resolves allegations brought by the Department of Justice that Exactech violated the False Claims Act by selling knee implants with components that failed prematurely.
By Elise Reuter • Sept. 19, 2025 -
Alamy
FDA posts early alert about Abbott’s Tactiflex Ablation Catheter
Catheter tips came off three damaged devices during surgery but none of the patients suffered serious injuries or died.
By Nick Paul Taylor • Updated Sept. 22, 2025 -
Permission granted by Becton Dickinson
BD expands Class I recall to cover 15 more Alaris pump infusion sets
BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded recall.
By Nick Paul Taylor • Sept. 17, 2025 -
Martin Barraud via Getty Images
AI devices with no clinical validation tied to more recalls, study finds
Public companies, which accounted for about half of AI-enabled devices on the market, had a higher rate of recalls and a lower rate of clinical evidence, according to a JAMA study.
By Elise Reuter • Sept. 2, 2025 -
Courtesy of Abiomed
J&J removes some Abiomed heart pump controllers from market
Abiomed reported one death associated with a pump driver circuit assembly that does not meet current specifications. The recall affects 69 controllers, a J&J spokesperson said.
By Susan Kelly • Aug. 28, 2025 -
Courtesy of Boston Scientific
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 Nick Paul Taylor • Aug. 25, 2025 -
Alamy
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 Nick Paul Taylor • Aug. 19, 2025 -
Courtesy of Draeger
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 Elise Reuter • Aug. 12, 2025 -
Courtesy of Boston Scientific
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 Nick Paul Taylor • Aug. 8, 2025 -
Alamy
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 Nick Paul Taylor • Aug. 7, 2025 -
Courtesy of Tandem Diabetes Care
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 Elise Reuter • Aug. 7, 2025 -
Patrik Stollarz / Staff via Getty Images
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 Elise Reuter • Aug. 5, 2025 -
Courtesy of Johnson & Johnson
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 Nick Paul Taylor • Updated July 29, 2025 -
Alamy
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 Nick Paul Taylor • July 25, 2025 -
Sascha Schuermann via Getty Images
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 Nick Paul Taylor • July 23, 2025 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • July 17, 2025 -
Courtesy of Abiomed
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 Nick Paul Taylor • Updated July 8, 2025 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • June 27, 2025 -
Courtesy of Medtronic
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 Ricky Zipp • June 25, 2025 -
Stringer via Getty Images
GE Healthcare recalls Carestation devices over ventilation failure risk
The recall affects 15 Carestation models and more than 14,000 individual devices.
By Nick Paul Taylor • June 24, 2025 -
Stock via Getty Images
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 Nick Paul Taylor • June 18, 2025 -
Courtesy of Dexcom
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 Elise Reuter • Updated June 24, 2025
