Recalls: Page 2
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Sara Silbiger via Getty Images
Smiths Medical recalls syringe pumps for software malfunction
The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.
By Nick Paul Taylor • Feb. 15, 2024 -
Retrieved from Food and Drug Administration.
Cardinal Health expands recall of Monoject syringes amid compatibility problems
The company said there have been no reports of patient deaths, but noted there is a risk of serious injury or death.
By Nick Paul Taylor • Feb. 5, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA receives more reports of deaths linked to Philips’ recalled respiratory devices
From the start of July to the end of September last year, the agency received more than 7,000 reports that contained 111 deaths.
By Nick Paul Taylor • Feb. 1, 2024 -
Alex Wong/Getty Images via Getty Images
GAO to review FDA’s oversight of medical device recalls
The government watchdog has accepted a request made in December by Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn.
By Ricky Zipp • Jan. 18, 2024 -
Courtesy of Resmed
Resmed’s magnetized masks linked to 6 patient injuries, FDA says
The company contacted customers in November after determining magnets should be kept away from active implants and metallic medical devices.
By Nick Paul Taylor • Jan. 12, 2024 -
Sara Silbiger via Getty Images
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice
The J&J unit limited the use of the product in children after receiving reports of burn injuries that could be particularly harmful to them.
By Nick Paul Taylor • Jan. 9, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips recalls MRI machines due to risk of explosion
The Food and Drug Administration labeled the recall as a Class I event. There has been one report of a machine exploding in the 22 years the system has been in use.
By Nick Paul Taylor • Dec. 22, 2023 -
Alex Wong/Getty Images via Getty Images
In wake of Philips recall, senators urge review of FDA medical device oversight
Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.
By Susan Kelly • Dec. 14, 2023 -
Tim Boyle via Getty Images
Baxter sends another safety notice about syringe infusion pump errors
The company shared “reinforced guidance” to mitigate the risk of underdosing and interruptions to treatment.
By Nick Paul Taylor • Updated Dec. 6, 2023 -
Permission granted by Becton Dickinson
BD tells customers not to use Cardinal’s Monoject syringes with Alaris pumps
The FDA labeled BD's safety notice as a Class I event. The warning comes amid several actions from the agency on the safety of syringes.
By Nick Paul Taylor • Dec. 4, 2023 -
Retrieved from Food and Drug Administration on December 01, 2023
FDA advises against using plastic syringes made in China amid reports of quality failures
Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes.”
By Nick Paul Taylor • Dec. 1, 2023 -
Sara Silbiger via Getty Images
Unomedical recall of infusion sets tagged as Class I by FDA
The company notified Tandem Diabetes Care, its sole consignee, in October of the risk for infusion sets to detach from insulin pumps, disrupting insulin delivery.
By Nick Paul Taylor • Nov. 28, 2023 -
Андрей Клеменков via Getty Images
FDA weighs in on SoClean’s field correction for CPAP cleaning machines
SoClean announced a voluntary field action last week to address user complaints related to improper set-up and unauthorized modifications.
By Nick Paul Taylor • Nov. 22, 2023 -
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes
Days after posting the Class 1 recall notice, the FDA said changes made to certain syringes could lead to overdose, underdose, or delays in therapy or alarms.
By Nick Paul Taylor • Nov. 21, 2023 -
Sarah Silbiger via Getty Images
B. Braun infusion pump safety correction linked to 51 complaints, one death
While no devices need to be removed, the FDA labeled the correction a Class I recall due to the risk of injury or death for patients.
By Nick Paul Taylor • Nov. 20, 2023 -
Retrieved from Food and Drug Administration.
Cardinal’s changes to disposable syringes trigger FDA Class I recall notice
The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.
By Nick Paul Taylor • Nov. 15, 2023 -
Retrieved from Medtronic on October 05, 2023
Stolen Medtronic laryngoscopes deemed Class 1 recall
Some of the defective devices turned up on Facebook Marketplace before the posting was taken down, the FDA said in the recall notice.
By Susan Kelly • Nov. 15, 2023 -
Sara Silbiger via Getty Images
Olympus receives Class I recall label for another bronchoscope safety issue
The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.
By Ricky Zipp • Updated Dec. 21, 2023 -
Patrik Stollarz / Staff via Getty Images
11 key moments in Philips’ massive recall of respiratory devices
The recall of millions of sleep apnea devices and ventilators is still ongoing more than two years later, as Philips works to repair and replace affected machines.
By Elise Reuter • Oct. 31, 2023 -
IOS/Zuma Press/Newscom
TrackerTracking Philips Respironics recalls
Philips issued a recall after finding a software malfunction could affect several models of ventilators, for a total of more than 146,000 devices.
By Elise Reuter • Updated April 18, 2024 -
Permission granted by Philips
Philips leader signed off on sale of respiratory devices despite evidence of health risks: report
Roy Jakobs approved the sale of respiratory devices held by manufacturers after the company stopped shipping new machines, according to an article published last week by Pittsburgh Post-Gazette and ProPublica.
By Nick Paul Taylor • Oct. 30, 2023 -
saengsuriya13 via Getty Images
Fresenius’ work to replace hemodialysis tubing flagged as Class I recall by FDA
Agency officials warned healthcare professionals last year about the potential for silicone tubing to expose patients to toxic compounds.
By Nick Paul Taylor • Oct. 25, 2023 -
Sara Silbiger via Getty Images
Olympus recall of abdominal insufflation devices linked to reports of 10 serious injuries, 1 death: FDA
The Food and Drug Administration labeled the recall a Class I event.
By Ricky Zipp • Updated Oct. 30, 2023 -
Courtesy of Abiomed/J&J
J&J’s Abiomed hit with FDA warning letter over Impella heart pump
The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.
By Susan Kelly • Oct. 12, 2023 -
Courtesy of Philips
FDA says Philips’ testing of recalled devices is inadequate
The regulator called for further tests to evaluate health risks posed to patients from the sound abatement foam used in the devices.
By Elise Reuter • Oct. 6, 2023
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