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Medicine Recalls

Vyaire Medical recalls Twin Tube due to potential nozzle separation risk posing a choking hazard. 5/23/2024

Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices. 5/22/2024

The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during implant of the LVAD device. 5/15/2024

The FDA issues alert about risk of false results with Cue Health's COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance. 5/13/2024

Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation. 5/13/2024

Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip separating near the marker band. 5/10/2024

Health care providers and facilities should begin to transition away from these devices and seek alternatives. 5/8/2024

Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery 5/8/2024

BioMerieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells. 4/30/2024

SonarMed Airway acoustic sensors recalled due to a restricted inner diameter resulting in difficulty passing a suction catheter through the sensor. 4/29/2024

SonarMed Airway monitors recalled for a software issue where it fails to detect partial obstructions in 2.5mm sensors and within 3mm of sensor tip. 4/29/2024

Elekta recalls Disposable Biopsy Needles (911933) from batch 837838839 due to potential microscopic stainless steel debris inside. 4/26/2024

These choking rescue protocols include abdominal thrusts (also called the "Heimlich" maneuver) for children and adults but not anti-choking devices. 4/26/2024

The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power. 4/25/2024

Fresenius Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter may expose patients who weigh less than 40 kg to higher than allowable levels of NDL-PCBA. 4/25/2024

Nimbus and Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. 4/25/2024

The Tablo Hemodialysis System may expose patients to higher than allowable levels of NDL-PCBAs. 4/25/2024

DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected. 4/24/2024

Obsidio Embolic may cause bowel ischemia if used with the aliquot technique to address lower GI bleeding. 4/17/2024

Fresenius Kabi is recalling Ivenix Infusion System (IIS), LVP, due to several software issues that could cause serious harm or death to patients. 4/17/2024

HeartMate II and HeartMate 3 devices are being recalled because a buildup of biological material is obstructing the device, making it more difficult for the heart to pump blood. 4/15/2024

Medos International Sarl is recalling Cerenovus CEREBASE DA Guide Sheath due to fractures in the distal catheter shaft where parts are joined. 4/4/2024

Smiths Medical ParaPAC Plus ventilators are used in transport and emergencies. A malfunction keeps the ventilator from providing necessary breathing support. 4/4/2024

ARROW QuickFlash Catheterization Kits are being recalled after reports of increased resistance with the guide wire and chamber during use. 4/3/2024

East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white... 3/28/2024

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