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

FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others.

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 incompl

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

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.

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.

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

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.

MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ 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 on

The FDA posts letters to health care providers about the safe use of medical devices.

Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions

Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops).

Learn about the issue, the FDA's recommendations and actions, how to report a problem, and contact information.

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

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

BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells.

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

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.

2024 Medical Device Recalls

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