FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr I…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manu…
View FDA Recall →Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to…
View FDA Recall →Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba…
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present …
View FDA Recall →Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscop…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
View FDA Recall →FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation C…
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
View FDA Recall →Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or int…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interrup…
View FDA Recall →Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for profe…
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case c…
View FDA Recall →Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf…
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along t…
View FDA Recall →Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba…
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present …
View FDA Recall →Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at …
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