Bezel posts on the Alaris Infusion Pump Module 8100 are critical to pump function. Step-Har repair bezel posts may crack or separate.
There is likely a high risk of false results using these tests. The tests are not FDA authorized, cleared, or approved.
The SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) have a likely risk of false results
Read more on the domestic supply of new respirators, including N95s and other FFRs, elastomeric respirators, powered air-purifying respirators (PAPRs)
FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure
This recall has been initiated due to the presence of undeclared Methanol. Use of or consumption of this product can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma & or permanent damage to the nervous system or death. Although all persons using these produc
Medical convenience kits group devices together for medical providers. The MAI kits contain ChloraPrep 3mL and is under recall for fungal contamination risk.
The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms.
The VICI SDS and RDS VENOUS STENT Systems treat narrowed or blocked venous veins. There is a recall because the stents may migrate after implantation.
Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure.
The FDA is alerting patients who had mammograms at Capitol Radiology, LLC in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms.
FDA reminds the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling all Dibar Labs Hand Sanitizer packaged in 8oz and 16 oz bottles, respectively, to the consumer level (see Label 1 below). Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2oz
Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary recall of Durisan Non Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Bu
List of Medical Device recalls in 2021.
Scentsational Soaps & Candles, Inc., has voluntarily expanded its April 27 recall of scented Hand Sanitizers to include three lots of Goose Creek HAND SANITIZER (NDC 75078-004) + Aloe and one lot of COCO TKO HAND SANITIZER in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer leve
Assurity™ and Endurity™ implantable pacemakers correct bradycardia. Moisture may enter some devices, causing electrical problems and shorter battery life.
Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of Medically Minded hand sanitizers, lot numbers: E212020 & E082020 Best Buy of 5/21/2022 to the user/consumer level. FDA analysis has found the product to contain methanol.
The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.
Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed below in Tabl