FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 65 of 520
Moderate Aug 21, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure vi…
DKK Dai-Ichi Shomei Co., Ltd.
Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiograph…
Merit Medical Systems, Inc.
Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Managem…
Merit Medical Systems, Inc.
Moderate Aug 21, 2024
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately…
Thoratec LLC
Moderate Aug 14, 2024
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forc…
Olympus Corporation of the Americas
Critical Aug 14, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutan…
Smiths Medical ASD Inc.
Moderate Aug 14, 2024
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reproce…
Steris Corporation
Moderate Aug 14, 2024
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nucl…
GE Medical Systems, LLC
Critical Aug 14, 2024
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 14, 2024
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, …
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Siemens Medical Solutions USA, Inc
Moderate Aug 14, 2024
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography wit…
GE Medical Systems, LLC
Moderate Aug 14, 2024
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocesso…
Steris Corporation
Moderate Aug 14, 2024
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reproce…
Steris Corporation
Moderate Aug 14, 2024
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 14, 2024
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Baxter Healthcare Corporation
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
GE Medical Systems, LLC
Moderate Aug 14, 2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
W.L. Gore & Associates, Inc.
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care prof…
Philips North America Llc
Moderate Aug 14, 2024
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with Syner…
Artivion, Inc
Moderate Aug 14, 2024
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 14, 2024
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care prof…
Philips North America Llc
Moderate Aug 14, 2024
American Contract Systems Spine Pack convenience kit
American Contract Systems, Inc.
Critical Aug 14, 2024
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALE…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Aug 14, 2024
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syst…
GE Medical Systems, LLC
Moderate Aug 14, 2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Olympus Corporation of the Americas
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging…
GE Medical Systems, LLC
Moderate Aug 14, 2024
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forc…
Olympus Corporation of the Americas
Moderate Aug 14, 2024
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance …
GE Medical Systems, LLC
Moderate Aug 14, 2024
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
CareFusion 303, Inc.
Moderate Aug 14, 2024
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems, LLC
Moderate Aug 14, 2024
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Siemens Medical Solutions USA, Inc
Moderate Aug 14, 2024
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear M…
GE Medical Systems, LLC