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October 18, 2021 at 12:00 AM
Do not use ultrasound gels and lotions manufactured by Eco-Med, as these products are at risk for bacterial contamination.
October 15, 2021 at 12:00 AM
False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA.
October 15, 2021 at 12:00 AM
Abbott is recalling Alinity m SARS-CoV-2 and Alinity m Resp-4-Plex AMP Kits because they may cause false positive SARS-CoV-2 results
October 14, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
October 14, 2021 at 12:00 AM
Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches
October 14, 2021 at 12:00 AM
False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA.
October 14, 2021 at 12:00 AM
Abbott is recalling Alinity m SARS-CoV-2 and Alinity m Resp-4-Plex AMP Kits because they may cause false positive SARS-CoV-2 results
October 13, 2021 at 12:00 AM
The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.
October 12, 2021 at 8:31 AM
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
October 12, 2021 at 12:00 AM
How to optimize dose accuracy when using ENFit LDT syringes – recommendations for patients and health care providers
October 12, 2021 at 12:00 AM
Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Speci
October 08, 2021 at 8:31 AM
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
October 08, 2021 at 12:00 AM
The FDA warns public and health care providers not to use needle-free devices for injection of dermal fillers.
October 07, 2021 at 12:00 AM
The FDA is providing updated recommendations to help protect patient safety and reduce the risk of adverse events associated with surgical staplers.
October 06, 2021 at 12:00 AM
Imperative Care is recalling ZOOM 71 Reperfusion Catheter, used to remove blood clots in the brain, due to risk of breaking during use.
October 06, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
October 06, 2021 at 12:00 AM
DeRoyal Industries Recalls Procedure Packs Containing NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching
October 05, 2021 at 9:00 AM
List of Medical Device recalls in 2020.
October 05, 2021 at 8:31 AM
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
October 05, 2021 at 12:00 AM
Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.
October 05, 2021 at 12:00 AM
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
October 05, 2021 at 12:00 AM
Medtronic recalled all remote controllers used with the MiniMed 508 and Paradigm family of insulin pumps due to potential cybersecurity risks.
October 05, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
October 01, 2021 at 12:00 AM
The FDA is informing patients, caregivers and health care providers of risk of device component breaking in patients with Stryker’s STAR Ankle Replacements.
October 01, 2021 at 12:00 AM
Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products