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Medicine Recalls

MEGA SOFT Pediatric Patient Return Electrodes used during monopolar electrosurgery may cause serious burn injuries to patients. 6/13/2024

Arrow FiberOptix and UltraFlex IAB Catheter Kits provide circulatory support. A manufacturing issue may prevent the balloon from fully inflating. 6/13/2024

Vaporizer Sevoflurane Maquet Filling is part of the Flow anesthesia systems but may expose patients or health professionals to toxic hydrogen fluoride. 6/13/2024

Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot... 6/12/2024

Medline Industries, LP is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other components from the main tube. 6/11/2024

Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment... 6/11/2024

The software error may cause numbers or letters to be missing from the displayed text and may result in the mechanical depth stop being set too short or too long. 6/5/2024

Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. 5/30/2024

Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel... 5/29/2024

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

Hospira, Inc., a Pfizer company ("Pfizer"), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for... 5/22/2024

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

MEGADYNET is initiating a voluntary recall of all MEGADYNET MEGA SOFTT Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation... 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

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