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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Microbiologics Inc recalled KWIK-STIK 2-Pack quality control product because affected units may fail to recover the target Campylobacter jejuni microorganism used in laboratory procedures.
Microbiologics is recalling certain LYFO Disk products containing Campylobacter jejuni because the organisms may not be recoverable, potentially affecting laboratory quality control procedures.
GE Healthcare is recalling Carestation anesthesia systems that may shut down unexpectedly during power loss, potentially disrupting mechanical ventilation and volatile agent delivery. This FDA Class I recall affects 888 units distributed worldwide.
GE Healthcare is recalling Carestation anesthesia systems that may unexpectedly shut down if AC power is lost, potentially disrupting ventilation and anesthetic delivery during surgery.
Fresenius Kabi is recalling Ivenix Infusion System software versions 5.10.1 and earlier due to software anomalies that could cause serious patient harm or death.
GE Healthcare Carestation 600 and 700 Series anesthesia systems with certain power boards may unexpectedly shut down during AC power loss, with temporary disruption of ventilation and loss of previous settings after reboot.
Myofunctional Research Company USA is recalling 436 Myosa for Kids mouthguards distributed nationwide and in Australia without FDA premarket clearance. The devices are intended for children ages 3-15 to address breathing and myofunctional disorders.
AVID Medical is recalling Halyard MIDTOWN GENERAL ARTERIOGRAM devices due to potential incomplete seals on header bags that could compromise product sterility. Approximately 300 units (Lot 1635477) were distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.
Rocket Medical Plc is recalling Rocket 16Fg Seldinger Catheter Procedure Trays because labeling contains misleading statements that may lead to improper device securing, creating a risk it may fall out during use.
The Patient History tab in ViewPoint 6 ultrasound software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.
DSAART LLC is recalling AART Calf Implants due to manufacturing deviations from specifications and distribution without required FDA premarket approval. No injuries reported.
AVID Medical is recalling the Halyard surgical pack due to potential incomplete sealing of the header bag, which may compromise sterility. The recall affects 90 units distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.
Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter with Safety Guard due to misleading labeling in device kit instructions that may result in improper securing and potential device dislodgement.
Copan Italia is recalling DTT reagent for use with the WASP specimen processor because functionality for liquifying respiratory specimens cannot be guaranteed. Approximately 122,850 units were distributed across 14 U.S. states.
Rocket Medical is recalling its 18Fg Seldinger Catheter Procedure Tray due to misleading instructions in device labeling that could lead to improper securing and potential device displacement.
DSAART LLC is recalling AART Silicone Carving Implants across multiple models due to manufacturing deviations from specifications and distribution without required FDA premarket approval. The recall affects 369 implants distributed to 28 U.S. states, Washington D.C., and Puerto Rico.
Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter Procedure Tray (635 units) due to misleading labeling that may cause improper securing of the chest tube, risking device fall-out during use.
SeaSpine Orthofix recalls NorthStar OCT Navigation Surgical Technique Guides due to incorrect identification of compatible Medtronic toolcards; only Solera toolcards are compatible, not Infinity toolcards.
The InPen App for Android may fail to show notification settings when reinstalled, preventing users from enabling reminders for insulin therapy. This could cause missed insulin doses and blood sugar elevation.
Medline Industries is recalling sterile surgical scissors with Item Number DYND04000 due to weak packaging seals that may breach sterility. If the seal fails, there is an increased risk of infection when the product is used.
Rocket Medical Plc is recalling the Rocket 18Fg Seldinger Catheter with Safety Guard due to misleading labeling that may result in improper securing and device displacement during use.
Certain MADSEN ACCUSCREEN hearing test probes may give false PASS results due to acoustic distortions from a speaker replacement. This could cause actual hearing loss to go undetected.
Zimmer Surgical Inc is recalling 839 units of the Zimmer Air Dermatome Model 00880100100 due to potential misalignment of the thickness control bar, which could affect proper operation during skin grafting procedures.
Mindray's BeneVision DMS workstations with specific hardware may experience audio playback failure or screen freezing, affecting patient monitoring capability.
AVID Medical is recalling 56 units of the Halyard HEAD AND NECK TRAY due to a potential for incomplete seal on the header bag, which could compromise product sterility. The recall affects units distributed in Georgia, Illinois, Nebraska, and Maryland.
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