Recalls: Page 2
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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 -
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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 -
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 -
Sarah Silbiger via Getty Images
Medline, Chinese manufacturer launch recalls for plastic syringes
Medline and Jiangsu Shenli Medical Production are at the center of the FDA’s probe of plastic syringes made in China.
By Ricky Zipp • May 24, 2024 -
Retrieved from Hologic on May 23, 2024
Hologic recalls more than 53,000 radiographic markers linked to 71 injuries
The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.
By Nick Paul Taylor • May 23, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls more than 1M angiographic catheters
Hospitals should discontinue use of the devices and return them due to potential safety risks, Boston Scientific wrote in a March letter to customers.
By Susan Kelly • May 15, 2024 -
Courtesy of Abbott
Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
By Susan Kelly • Updated May 16, 2024 -
Mario Tama via Getty Images
J&J’s Megadyne discontinues pediatric electrode pad after burn reports
Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures when the electrode pads were used.
By Nick Paul Taylor • May 13, 2024 -
Sarah Silbiger via Getty Images
Route 92 catheter recall tied to 2 injuries, 1 death
The affected devices were manufactured by an outside supplier, not Route 92, and had product quality problems.
By Nick Paul Taylor • May 13, 2024 -
Courtesy of Tandem Diabetes Care
Tandem reports 224 injuries related to faulty insulin pump app
A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.
By Nick Paul Taylor • May 9, 2024 -
Courtesy of Getinge
FDA tells providers to stop using Getinge heart devices
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
By Nick Paul Taylor • May 9, 2024 -
Retrieved from Food and Drug Administration.
Cardinal receives FDA warning letter over unapproved syringes
The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
By Elise Reuter • May 2, 2024 -
N/A via Getty Images
Philips reaches major settlements related to respiratory devices recall
A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.
By Elise Reuter • May 2, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips agrees to $1.1B settlement of US respiratory recall lawsuits
CEO Roy Jakobs said on a first-quarter earnings call that “for the U.S., this is as final as it can get.”
By Nick Paul Taylor • April 29, 2024 -
Courtesy of Fresenius Medical Care
Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk
Nearly 2.2 million devices are affected by the recall. Fresenius Medical Care will not have to remove products due to the issue.
By Nick Paul Taylor • April 26, 2024 -
Courtesy of U.S. Food and Drug Administration
Infutronix infusion pump recall linked to 6 injuries, 1 death
The FDA’s recall notice sheds light on the impact to patients weeks after the company told customers it would pull Nimbus pumps from the market.
By Nick Paul Taylor • April 26, 2024 -
Courtesy of Philips
Judge approves settlement of more than $500M from Philips recall
Philips could be on the hook for more costs if eligible claims for recalled or returned respiratory devices exceed the amount agreed to in the settlement.
By Elise Reuter • April 25, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips failed to report corrections of CT machines, FDA says in warning letter
After a 2023 inspection, the FDA found three unreported field corrections related to CT machines and 19 other recalls of radiology devices.
By Elise Reuter • April 25, 2024 -
Sarah Silbiger via Getty Images
Exactech recalls shoulder devices after initially declining to act
After the FDA issued a public safety notice and sent Exactech a warning letter, the firm agreed to recall shoulder implants due to packaging issues.
By Nick Paul Taylor • April 22, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
By Nick Paul Taylor • April 18, 2024
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