Search results for Brazil Regulator Suspends Medical Devices Over Packaging Defects

Brazil regulator suspends medical devices over packaging defects

Brazil’s regulator Anvisa has suspended selected medical devices after identifying packaging defects that could compromise sterility and patient safety. The post Brazil regulator s...

Health authorities order halt to use of medical devices tied to patient’s death

Hong Kong health authorities have ordered hospitals to stop using a batch of blood pressure monitoring sets after an improperly sealed device was linked to the death of an elderly...

Planned heart procedures delayed at at least 25 Dutch hospitals after device recall

Elective heart procedures are being postponed in Dutch hospitals after a recall of a medical device used in cardiac catheterization, while emergency care for heart attacks and othe...

Medline hit with FDA warning letter over defective heart syringes, safety hazards

After Medline pulled off a massive $6.26 billion IPO late last year, the company now finds itself facing serious concerns being leveled by the FDA.

Authorities suspend aesthetic clinic over patient safety risks

Finnish authorities have ordered the immediate suspension of operations at an aesthetic clinic in Espoo after inspectors found unlicensed medicines, improper storage practices and...

IV Device Redesign Not Enough To Lift Ban, CBP Says

A U.S. medical device company's redesigned products used for intravenous drips are still barred from importation into the country, U.S. Customs and Border Protection said in an ord...

FDA issues most serious recall for certain pacemaker devices by Boston Scientific

The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after ide...

FDA identifies recall of catheter kits, Early Alert for sterile labels

The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable...

Brazil increases import tax on batteries at local manufacturer’s request

The measure raises the import tariff from 18% to 25% for 48V LFP batteries intended for stationary applications in telecommunications and photovoltaic systems of up to 4.8 kW until...

China deal helps Malaysia avoid medical device shortages, says Health Ministry

KUALA LUMPUR, April 20 — The supply of medical devices in Malaysia remains stable and under control despite the gl...

FDA announces shortage of products used for neurosurgery, microsurgery expected to continue remainder of 2026

The Food and Drug Administration announced May 6 that it is aware of a shortage of neurosurgical patties, sponges and strip devices across the U.S. due to supplier issues, and expe...

Philips recalls Trilogy Evo ventilator software, warns of ‘under-delivery’ of therapy

Philips issued a voluntary recall of software for its series of Trilogy Evo ventilators as well as a warning for patients not to use non-pneumatic nebulizers with the devices becau...

Insulet issues voluntary correction for Omnipod devices in leaky insulin fault

Insulet has sent out a voluntary medical device correction notice for a series of its Omnipod devices amid a manufacturing fault that could lead to insulin leaking and not being fu...

South Africa: Court Sets Aside National Tender for Circumcision Device

[GroundUp] With immediate effect the CircumQ device may not be used on boys aged ten to 14

Brazil expands pesticide packaging reverse logistics

Brazil is strengthening its reverse logistics system for pesticide packaging with the rollout of a nationwide itinerant collection programme. The post Brazil expands pesticide pack...

<![CDATA[FDA Places Full Clinical Hold on Aardvark Therapeutics’ ARD-101]]>

Latin America’s largest hospital complex cancels plan to buy shark meat

The University of São Paulo Medical School Hospital said it would cancel a plan to buy more than 17 metric tons of shark meat as part of a 2026 procurement, citing concerns over he...

EU plans to ban meat exports from Brazil

Rules on imports will apply beginning Sept. 3, 2026

Tandem Diabetes issues software device correction for insulin pump malfunction

Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that can fail to deliver critical medicine to patients.

Austria recalls baby food jars in health scare

A supplier of baby food jars in Austria is recalling a line saying a lethal substance may have been introduced through tampering.

Thermos Recalls 8.2 Million Jars and Bottles After Customers Are Injured

The company received reports that the stoppers on some of its products had “forcefully ejected,” striking customers and causing permanent vision loss in a few cases, safety regulat...

Medtronic to shutter Santa Rosa plant as it restructures cardiovascular unit

Medtronic will shutter its Santa Rosa facility that produces coronary stents and other heart-related products over the next two years as the device maker also looks to restructure...

Commission: Once Brazil demonstrates ‘compliance’ exports can resume

The European Commission has said Brazil will be able to resume exports to the EU once it shows “compliance” with restrictions on antimicrobial use in food-producing animals. The co...

MCAZ orders recall of Azithromycin batch over quality defect, patients urged to return stock

THE Medicines Control Authority of Zimbabwe (MCAZ) has ordered the recall of a batch of a widely used antibiotic Azithromycin after it failed quality tests. Zimbabwe’s medicines re...