Class IIOngoingZ-2006-2026
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Elekta, Inc.GAMay 6, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–72 of 621 recalls
Class IIOngoingZ-1948-2026
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchron…
Medtronic, Inc.MNMay 6, 2026
Class IOngoingZ-1827-2026
WHILL, INC. recalls WHILL Model F
Cyber vulnerability of BLE communication was found by CISA VDP program.
WHILL, INC.May 6, 2026
Class IOngoingZ-1826-2026
WHILL, INC. recalls WHILL Model C2
Cyber vulnerability of BLE communication was found by CISA VDP program.
WHILL, INC.May 6, 2026
Class IIOngoingZ-1909-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1908-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1907-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1906-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1905-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1904-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1903-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
XXX
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1902-2026
Olympus Corporation Of The Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of…PAApr 29, 2026