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Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter. Read More
Hamilton Medical has recalled its G5 Ventilator, following one report of device malfunction due to ventilation and alarm failure, the FDA says in a recall alert issued in November. Read More
Failure to conduct adequate investigations of complaints related to its volumetric infusion pumps and not providing corrective action documents are among the issues that have landed WalkMed Infusion an FDA warning letter. Read More
CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
Mobile stroke units, medical device cybersecurity and wireless wearable sensors lead ECRI Institute’s 2016 list of the top 10 technological advances that are poised to affect care delivery over the next 12 to 18 months. Read More
eVent Medical has implemented a Class 1 recall of its Inspiration ventilators, citing a faulty switch on the power board that may fail, causing the device to shut down without sounding an alarm. Read More
Novartis’ Alcon unit is recalling more than 43,000 units of its AcrySof IQ Toric, expanding a previous recall of more than 45,000 intraocular lenses earlier this year in Japan. Read More
The FDA is ratcheting up requirements for surgical mesh for transvaginal repair of pelvic organ prolapse, issuing two final orders that address safety risks. Read More
bioMerieux is recalling 3,760 units of its Etest PIP/TAZO/CON-4 PTC 256 because its results could indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria, when it may not be effective in doing so. Read More
The FDA has hit the Dutch Ophthalmic Research Center’s Zuidland, Netherlands, facility with a warning letter for manufacturing adulterated devices. Read More