DeRoyal Industries Recalls Procedure Packs Containing NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching
List of Medical Device recalls in 2020.
Medtronic recalled all remote controllers used with the MiniMed 508 and Paradigm family of insulin pumps due to potential cybersecurity risks.
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.
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
The FDA is informing patients, caregivers and health care providers of risk of device component breaking in patients with Stryker’s STAR Ankle Replacements.
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products.
Max-Lux Safe-T-Lite UV-C WAND may cause injury to the skin, eyes, or both after a few seconds of use.
Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices.
Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level
Certain canisters of AMBSORB PLUS used to absorb carbon dioxide during anesthesia may cause difficulties in gas flow, resulting in reduced flow to patients.
This catheter is used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media.
Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting
Pipeline Flex Embolization Devices are intended to treat wide-neck and fusiform brain aneurysms. Pieces of the delivery system may break off while in use.
False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA.
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer
Smiths Medical ASD Inc is recalling the NORMOFLO Irrigation Fluid Warmer and Warmers Sets because of the potential for aluminum ions leaching into warmed fluids.
The FDA is alerting health care providers about the use of certain fluid warmers and the potential for aluminum leaching.
Listing of the 2021 Biologics Recalls