Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used.
Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death.
Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.
The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa
Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.
Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.
The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.
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