Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 174 of 548
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. O…
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Stryker Spine
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized,…
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jul 28, 2021
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Encore Medical, LP
FDA Devices Moderate Jul 28, 2021
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytoge…
Soft Computer Consultants, Inc.
FDA Devices Moderate Jul 28, 2021
Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jul 28, 2021
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by sque…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 28, 2021
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Cell Marque Corporation
FDA Devices Low Jul 28, 2021
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Mode…
Mindray DS USA, Inc. dba Mindray North America
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; an…
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized,…
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL …
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector t…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and…
Exactech, Inc.
FDA Devices Moderate Jul 28, 2021
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)…
Caption Health
FDA Devices Moderate Jul 28, 2021
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jul 28, 2021
Stimulen Collagen Moisturizing Lotion, ST9555B
Southwest Technologies Inc
FDA Devices Critical Jul 28, 2021
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is in…
Respironics California, LLC
FDA Devices Moderate Jul 28, 2021
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Stryker Spine
FDA Devices Critical Jul 21, 2021
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Philips Respironics, Inc.
FDA Devices Moderate Jul 21, 2021
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup c…
IMPLANTCAST GMBH
FDA Devices Moderate Jul 21, 2021
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short …
GE Healthcare, LLC
FDA Devices Moderate Jul 21, 2021
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventric…
Heartware, Inc.
FDA Devices Moderate Jul 21, 2021
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. …
Tornier, Inc
FDA Devices Moderate Jul 21, 2021
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Moderate Jul 21, 2021
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Axonics Modulation Technologies, Inc.
FDA Devices Moderate Jul 21, 2021
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Baxter Healthcare Corporation
FDA Devices Moderate Jul 21, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysi…
Arrow International Inc
FDA Devices Moderate Jul 21, 2021
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare, LLC
FDA Devices Moderate Jul 21, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporar…
Arrow International Inc
FDA Devices Critical Jul 21, 2021
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Philips Respironics, Inc.
FDA Devices Moderate Jul 21, 2021
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, an…
GE Healthcare, LLC
FDA Devices Critical Jul 21, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Boston Scientific Corporation
FDA Devices Moderate Jul 21, 2021
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of in…
Cordis Corporation
FDA Devices Moderate Jul 21, 2021
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Moderate Jul 21, 2021
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studi…
Arrow International Inc
FDA Devices Moderate Jul 21, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for tempor…
Arrow International Inc
FDA Devices Moderate Jul 21, 2021
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
C-RAD POSITIONING AB
FDA Devices Moderate Jul 21, 2021
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Devices Critical Jul 21, 2021
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Boston Scientific Corporation
FDA Devices Critical Jul 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Boston Scientific Corporation
FDA Devices Moderate Jul 21, 2021
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
RanD S.r.l.
FDA Devices Moderate Jul 21, 2021
SIGNA MR380, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
FDA Food Moderate Jul 14, 2021
Yakult Nonfat Probiotic Drink; Live and active Lactobacillus casei Shitota; 2.7 FL. OZ. (80 mL), 5 individual bottles per pack, 10 packs per case. Bo…
Yakult U.S.A. Inc.
FDA Devices Moderate Jul 14, 2021
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Boston Scientific Corporation
FDA Devices Moderate Jul 14, 2021
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles …
GE Healthcare, LLC
FDA Devices Moderate Jul 14, 2021
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective p…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient cover…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Vivorte, Inc.