Recalls 1610 articles

Resuscitator bags recalled due to defect

SunMed Holdings LLC is recalling 18,808 units of STAT-Check and Medline resuscitator bags due to a defect that could render the device unable to deliver air to the patient, which could result in a delay in treatment and life-threatening health consequence. There have been no injuries related to this issue, to date. STAT-Check and Medline resuscitator bags are hand-held devices commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. In the resuscitator bags affected by the recall, the patient port retaining ring may not fully seat, which may allow the patient port ... Read More

MedTronic heart device recalled due to electrical error

Medtronic is recalling more than 200,000 HeartWare Ventricular Assist Devices (HVAD systems) due to an electrical issue that could cause the device to disconnect from its electrical source, causing the pump to stop. This issue could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death. This recall is classified as a Class I recall, which is the most serious type of recall. Class I recalls are issued when use of a medical device may cause serious adverse events or death. The recall affects certain models ... Read More

Bits of glass in nasal spray prompts recall

Apotex Corp. is recalling an allergy nasal spray after a customer complained about finding bits of glass in a bottle of the medication. The glass particles could block the actuator and impact the pump. But even more disturbing is the risk that some users may inadvertently spray the glass up their noses. “Mechanical irritation cannot be ruled out,” the company said in a news release. “Local trauma to the nasal mucosa might occur with use of the defective product.” To date, Apotex Corp. has not received any repots of adverse events related to this issue. The recall affects lot # ... Read More

Birth control pills recalled due to packaging error

Allergan is recalling physician sample packs of the birth control pills Taytulla after receiving a physician report that four of the placebo capsules were placed out of order with the first four days of therapy having four non-hormonal capsules instead of active ones. The reversing of the order may not be apparent to either new users or previous users, increasing the likelihood of taking the capsules out of order. This error could put the user at risk for unintended pregnancy. Taytulla is a contraceptive used by women to prevent pregnancy. The recall involves lot number 5620706 of Taytulla softgel capsules ... Read More

Ice cream, sherbets recalled, may contain metal bits

H-E-B is recalling certain flavors and container sizes of EconoMax and Hill Country Fare ice cream and Creamy Creations sherbet because they may contain bits of metal from a broken part found in processing equipment during routine maintenance. The affected ice creams and sherbets were distributed to H-E-B stores in Texas and Mexico. To date, no injuries have been reported due to this incident. H-E-B says it has already removed all related products from its store shelves and intends to have a new shipment to replace them as soon as possible. The recall involves 4-quart, 4.5-quart, quart, and 56-ounce cartons ... Read More

Shave cream, acne products recalled due to potential contamination

Topical shave creams, acne products and pain gels manufactured by Shadow Holdings are being recalled because they may be contaminated with bacteria that could lead to serious infections in people with compromised immune systems. To date, no reports of adverse events have been associated with use of these products. Affected products include all lots within expiration date of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit. Herb-X Solutions X-Jow Pain Gel is an external analgesic, and is packaged in 4 oz. and 8 oz. bottles. ... Read More

Medtronic recalls revascularization device due to defect

Medtronic is recalling the MindFrame Capture LP revascularization device used to during procedures to treat strokes because the delivery wire may break or separate during use, leaving the clot retriever inside the patient’s bloodstream. This, or the attempts made to retrieve the device, can lead to further complications including bleeding, additional blockage of blood vessels, more severe stroke symptoms, or death. The MindFrame Capture LP revascularization device used to restore blood flow or remove blood clots within in a blood vessel in the brain during an acute ischemic stoke in patients ineligible for or who fail intravenous plasminogen activator (IV ... Read More

Cardiac support device recalled due to malfunction

Abbott is recalling nearly 5,000 HeartMate 3 Left Ventricular Assist Systems that provide cardiac support to critically ill patients due to a potential malfunction that could reduce the action of the pump and pose serious adverse events to patients including blood clots and death. The HeartMate 3 Left Ventricular Assist System helps deliver blood from the heart to the rest of the body. It is used for the short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant. The system includes a blood pump that is implanted ... Read More

Homeopathic products recalled due to quality concerns

MBI Distributing Inc., is recalling several of its homeopathic drug products used to treat a variety of ailments from colic to cough because they were found to be manufactured without adequate controls to ensure the products’ strength, quality and purity. Use of these products could cause health problems especially in vulnerable patients, like the infants and children for which many of the products are intended. To date, MBI Distributing has not received any reports of adverse events related to this recall. Products affected by the recall include all lots of MBI Distributing Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, ... Read More

Fiat-Chrysler Recalls Nearly 5 Million Vehicles For Cruise-Control Glitch

Fiat-Chrysler is recalling nearly 5 million U.S. vehicles to repair a software glitch that could prevent drivers from canceling the cruise control. The problem affects about 4.8 million Fiat-Chrysler cars, minivans, SUVs, and pickup trucks from model-year 2014 to 2018. According to the automaker, “a driver could be unable to cancel cruise-control” if the cruise control system accelerates at the same time a “short-circuit in a specific electrical network” occurs. Normally drivers disengage cruise control by tapping the brake or hitting the cruise-control on-off switch, but both methods can stop working if the glitch occurs. The National Highway Traffic Safety ... Read More