Recalls: Page 3
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Patrik Stollarz / Staff via Getty Images
Philips issues fix for ventilator problems linked to 9 injuries, 1 death
Philips is asking customers to immediately install a software update to address several new and previously reported safety issues, the FDA said.
By Elise Reuter • Oct. 2, 2024 -
magicmine via Getty Images
Recalled heart devices had limited clinical testing, study finds
Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.
By Elise Reuter • Sept. 24, 2024 -
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Sarah Silbiger via Getty Images
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 -
ChooChin via Getty Images
Zimmer pulls hip implant off the market due to fracture risk
The company plans to phase out use of its CPT Hip System by December, but the FDA is still concerned about implants in new patients.
By Elise Reuter • Sept. 18, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls airway tubes over defect linked to more than 10 injuries
Smiths has had seven Class I recalls, the most severe kind, so far in 2024.
By Elise Reuter • Sept. 16, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical links 1 death, 35 injuries to defective airway tubes
Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.
By Susan Kelly • Sept. 10, 2024 -
Kahan Shan via Getty Images
Inari updates label of clot removal device linked to 6 deaths
Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.
By Nick Paul Taylor • Aug. 27, 2024 -
Sarah Silbiger via Getty Images
Defibtech recalls chest compression device linked to patient death
Customers are asked to return affected devices due to a problem in the motor that could stop compressions.
By Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Tandem Diabetes Care
Tandem warns iPhone app still draining insulin pump batteries
Despite a software update in March, users are still reporting that the app is rapidly depleting their insulin pump batteries, causing unexpected shutdowns.
By Elise Reuter • Aug. 15, 2024 -
Retrieved from Breas Medical on August 12, 2024
Breas Medical flags risk of formaldehyde exposure in ventilators
Testing showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions.
By Nick Paul Taylor • Aug. 12, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls infusion pumps over software issues
The devices may fail to emit alarms, have unresponsive stop and power keys, and reveal passwords.
By Nick Paul Taylor • Aug. 9, 2024 -
Courtesy of Medtronic
Medtronic recalls nerve monitoring system linked to 10 injuries
Medtronic has asked users to be aware the devices may not alert when on a nerve, which could lead to injuries during surgery.
By Nick Paul Taylor • Aug. 7, 2024 -
Courtesy of Johnson & Johnson
FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.
By Nick Paul Taylor • Aug. 1, 2024 -
Permission granted by Abbott Laboratories
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings
A spokesperson for Abbott said the recall “may impact less than 1% of Libre 3 users in the U.S.”
By Nick Paul Taylor • July 26, 2024 -
Retrieved from Food and Drug Administration.
J&J limits use of Megadyne electrodes due to burn risk
The FDA said 15 injuries have been tied to the use of three models of Megadyne patient return electrodes.
By Elise Reuter • July 12, 2024 -
Courtesy of Medtronic
Medtronic recalls endotracheal tubes over blockage risk
The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.
By Nick Paul Taylor • July 11, 2024 -
FG Trade Latin via Getty Images
Philips recall of imaging coils tied to 12 injuries
Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.
By Ricky Zipp • July 9, 2024 -
Retrieved from Cardinal Health on July 02, 2024
FDA continues crackdown on plastic syringes made in China
The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.
By Elise Reuter • July 2, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA walks back injury, death reports on recent Philips BiPAP recall
The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.
By Elise Reuter • Updated July 11, 2024 -
Retrieved from Baxter on June 27, 2024
Baxter recalls ventilation systems for charging malfunctions
This comes a year after the healthcare company recalled the Life2000 Ventilation System due to oxygen desaturation risks.
By Ricky Zipp • June 27, 2024 -
Sarah Silbiger via Getty Images
Merit Medical recalls plastic syringes made by Jiangsu Shenli
Merit’s recall comes amid broader FDA scrutiny of plastic syringes made in China.
By Nick Paul Taylor • June 17, 2024 -
Sarah Silbiger via Getty Images
Teleflex catheter kit recall linked to 31 injuries, 3 deaths
Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.
By Nick Paul Taylor • June 14, 2024 -
Kevin Dietsch / Staff via Getty Images
Masimo embroiled in dual DOJ, SEC probes
Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.
By Susan Kelly • June 13, 2024 -
Sarah Silbiger via Getty Images
Abbott issues recall for Heartmate system monitor
Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.
By Susan Kelly • June 11, 2024 -
Courtesy of Medtronic
Medtronic recalls neurosurgery navigation system for software error
A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months.
By Elise Reuter • June 6, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips reports 7 deaths linked with BiPAP alarm problem
Philips recalled three BiPAP models because an alarm can incorrectly engage and shut down the ventilator under certain circumstances.
By Elise Reuter • May 29, 2024
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