Recalls
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Courtesy of Philips
Philips faces new recall of Evo respirators, tagged Class I by FDA
The woes are continuing for Philips and its Respironics unit, whose ventilators and other breathing assist devices have faced a slew of recalls.
By Peter Green • June 6, 2023 -
Courtesy of Abiomed/J&J
Abiomed heart pump recall labeled Class I by FDA, no deaths reported
The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.
By Peter Green • Updated June 5, 2023 -
N/A via Getty Images
Deaths reported with Philips ventilators, sleep apnea machines still climbing
The FDA reported 40 additional deaths tied to the recall of Philips’ devices in its latest update.
By Susan Kelly • Updated June 2, 2023 -
Retrieved from SD Biosensor / FDA on May 30, 2023
Recall of Roche partner’s COVID tests labeled as Class I
The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.
By Elise Reuter • Updated 12 hours ago -
Courtesy of Integra
Integra recalls all devices made at Boston facility in the past 5 years, pauses production
Integra initiated the recall after an internal investigation found endotoxin testing deviations that can result in postoperative fevers. Analysts at BTIG said the recall raises “bigger questions” about Integra’s management.
By Nick Paul Taylor • May 24, 2023 -
Patrik Stollarz / Staff via Getty Images
Philips loses vote as shareholders push back against handling of respirator recall
The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.
By Nick Paul Taylor • May 10, 2023 -
Courtesy of Illumina
Illumina gets cybersecurity warning from FDA over sequencing software
The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.
By Susan Kelly • Updated April 28, 2023 -
Sarah Silbiger via Getty Images
Post-approval modification of high-risk devices linked to 30% jump in recall risk: study
The authors suggest improved post-marketing surveillance systems may be needed to mitigate risks to patient safety.
By Nick Paul Taylor • April 18, 2023 -
Courtesy of Philips
Fewer Philips replacement devices have reached patients than counted, FDA says
The agency raised concerns that the discrepancy could affect the estimated wait times for patients needing a replacement sleep apnea device.
By Elise Reuter • April 14, 2023 -
Courtesy of Philips
Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure
The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.
By Nick Paul Taylor • April 10, 2023 -
Retrieved from Abbott on April 06, 2023
Abbott faces Class I recall of 4.2M glucose readers on battery fire risks
Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, the FDA says.
By Peter Green • Updated April 7, 2023 -
Courtesy of Philips
Philips Trilogy Evo ventilators face another Class I recall
More trouble for Philips’ Respironics business as the company flags a problem with ventilators that could lead to under-delivery of oxygen due to inaccurate readings.
By Elise Reuter • April 4, 2023 -
Permission granted by Philips
Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says
Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.
By Peter Green • March 31, 2023 -
Courtesy of U.S. Food & Drug Administration
Exactech implants may oxidize, FDA says, warning surgeons not to use any recalled joints
Exactech is recalling knee and total ankle replacements that were packaged in defective bags.
By Nick Paul Taylor • March 24, 2023 -
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 Nick Paul Taylor • March 3, 2023 -
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 Susan Kelly • Feb. 23, 2023 -
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 Nick Paul Taylor • Feb. 22, 2023 -
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 Nick Paul Taylor • Feb. 17, 2023 -
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 Nick Paul Taylor • Feb. 10, 2023 -
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 Susan Kelly • Jan. 30, 2023 -
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 Elise Reuter • Jan. 30, 2023 -
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 Nick Paul Taylor • Jan. 30, 2023 -
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 Elise Reuter • Jan. 23, 2023 -
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 Elise Reuter • Jan. 12, 2023 -
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 Elise Reuter • Dec. 21, 2022
