Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 194 of 548
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red …
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO …
Haag-Streit USA Inc
FDA Devices Moderate Dec 30, 2020
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
IceSeed" Prostate Cryoablation Kit
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…
B Braun Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin …
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 MRI Cryoablation Needle¿
Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Critical Dec 30, 2020
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding S…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fl…
Baxter Healthcare Corporation
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of…
Biocomposites, Ltd.
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 23, 2020
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultraso…
Boston Scientific Corporation
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used wit…
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Dec 23, 2020
3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-li…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) C…
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be im…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 1204…
Enterix, Inc.
FDA Devices Moderate Dec 23, 2020
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis …
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
Microsurgical Operating Room Tables;7300BX (18-351-70).
Mizuho America, Inc.
FDA Devices Moderate Dec 23, 2020
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and kerat…
Carl Zeiss Meditec AG
FDA Devices Moderate Dec 23, 2020
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: ar…
Medline Industries Inc
FDA Devices Moderate Dec 23, 2020
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
Microsurgical Operating Room Tables;7300B (18-350-70);
Mizuho America, Inc.
FDA Devices Moderate Dec 23, 2020
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the…
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Dec 23, 2020
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, s…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is i…
Medtronic Neuromodulation
FDA Devices Moderate Dec 23, 2020
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acqui…
Kowa Optimed Inc
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following …
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polym…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Synthes (USA) Products LLC