Class IIOngoingZ-1820-2025
GE Medical Systems, LLC recalls OEC 3D
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
GE Medical Systems, LL…WIJun 18, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 601–612 of 816 recalls
Class IIOngoingZ-1819-2025
GE Medical Systems, LLC recalls OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital s…
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
GE Medical Systems, LL…WIJun 18, 2025
Class IIOngoingZ-1900-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1899-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1898-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1897-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1896-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1895-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1894-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IIOngoingZ-1893-2025
Silex Medical, LLC recalls Signature Laparoscopic Instruments
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical, LLCCTJun 11, 2025
Class IOngoingZ-1814-2025
SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port).…
SunMed Holdings, LLCMIJun 11, 2025
Class IIOngoingZ-1876-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Ortho-Clinical Diagnos…NYJun 4, 2025