Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
GE HealthCare is recalling certain MAXXUS nuclear medicine systems that may have been transported without proper detector support, potentially compromising mounting mechanisms. No injuries have been reported to date.
Canon's VANTAGE GALAN 3T MRI machines may accumulate ice in the magnet vent system, preventing helium gas escape and potentially rupturing the helium vessel, causing gas release into the scanning room.
Medline is recalling robotics urology procedure kits with Stryker Strykeflow 2 Suction Irrigators due to a 2024 design change that allows irrigation solution to leak and emit vaporized saline during use.
Medline is recalling IV administration kits containing B. Braun components due to check valve defects that may become stuck. The kits were distributed nationwide and used in anesthesia procedures.
Instrumentation Laboratory is recalling approximately 7,720 coagulation testing devices due to potential microbial contamination. These devices are used to evaluate blood coagulation pathways and monitor heparin therapy.
Medline Industries is recalling 33 units of IV and pump administration sets due to check valve components that may become stuck in open or closed positions, potentially affecting fluid delivery.
CentriMag blood pumps may fail to lock securely into their motors, potentially preventing proper alarm activation and causing delays in circulatory support or serious complications.
Certain GE HealthCare nuclear medicine systems transported without proper detector support may have compromised mounting mechanisms, potentially resulting in detector fall and life-threatening injury. No injuries have been reported.
Heraeus Medical is recalling PALACOS R pro bone cement due to ampoule breakage within the device system. If ampoules don't break properly, appropriate cement cannot be formed for use.
Some Allura Xper FD20 operating room tables may lack a cooling unit drip tray, which could allow coolant to contact electrical components and cause system shutdown.
C-RAD Catalyst and Catalyst+ patient positioning systems for stereotactic radiosurgery may incorrectly indicate proper patient positioning, potentially compromising radiation treatment accuracy. Approximately 189 units have been distributed in 37 countries including the United States.
Elekta's MOSAIQ oncology system may deliver cancer treatment twice due to a software error in specific workflow scenarios involving partial treatments.
Hologic has recalled ThinPrep CytoLyt Solution due to fungal contamination detected in one lot. The buffered cell wash solution may cause infection if used in diagnostic procedures.
Medline has recalled approximately 1,725 IV Administration Sets containing B. Braun components because check valves may become stuck in open or closed positions, potentially preventing medication delivery or allowing uncontrolled fluid flow.
ICU Medical is recalling Portex Spinal Tray syringes due to cracks in the syringe collar. The defect may cause delayed blood draws, fluid leakage during arterial blood sampling, or improper delivery.
Philips is recalling Allura Xper FD10 X-ray systems with potentially missing drip trays beneath the cooling unit. If missing, coolant could contact electrical components, causing short-circuits and system shutdown.
Medicrea is recalling 44 units of the IB3D Universal Implant Inserter due to a mechanical defect where the handle may separate from the shaft, preventing proper implant rotation during surgery.
Medline is recalling IV administration kits containing B. Braun components because check valves may become stuck in the open or closed positions. The recall affects 338 units distributed nationwide.
Philips recalls Allura Xper FD20 Biplane systems with a missing cooling drip tray. Coolant exposure to electrical components could cause short-circuits and system shutdown.
Heraeus Medical recalls PALACOS MV pro bone cement products due to ampoule breakage defects that prevent proper mixing. Affected devices may fail to produce usable cement during surgical application.
ICU Medical recalls Plum Duo Infusion Systems with defective speakers that may fail to produce sound. If the speaker fails, patients and caregivers may not hear pump alarms or alerts.
Medtronic is recalling certain Abre Venous Self-Expanding Stent Systems due to a manufacturing defect that can reduce stent diameter and radial force when deployed, potentially causing the stent to migrate.
Medline is recalling medical procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators due to a 2024 design change that allows irrigation solution to leak into the handpiece and battery pack during use.
Medline surgical procedure kits containing Stryker Strykeflow 2 Suction Irrigators are recalled because a 2024 design change allows irrigation solution to leak into the handpiece and battery pack, potentially causing leakage or vaporized saline emission during use.
GE HealthCare recalls nuclear medicine systems that may have structural damage to detector mounting mechanisms due to improper transport. Damaged detectors could fall and cause serious injury, though no incidents have been reported.
Looking for a different category? Browse all recalls.