Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 163 of 548
FDA Devices Moderate Nov 24, 2021
REGARD Basic Cataract tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …
Cordis Corporation
FDA Devices Moderate Nov 24, 2021
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic S.R.L.
FDA Devices Moderate Nov 24, 2021
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and…
Cook Inc.
FDA Devices Moderate Nov 24, 2021
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a com…
Beaver Visitec International, Inc.
FDA Devices Moderate Nov 24, 2021
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Beaver Visitec International, Inc.
FDA Devices Moderate Nov 24, 2021
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay…
Bio-Rad Laboratories, Inc.
FDA Devices Moderate Nov 24, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
CooperSurgical, Inc.
FDA Devices Moderate Nov 24, 2021
REGARD Newborn Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary…
Cordis Corporation
FDA Devices Moderate Nov 24, 2021
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replac…
OmniLife Science
FDA Devices Moderate Nov 24, 2021
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for eval…
Beaver Visitec International, Inc.
FDA Devices Moderate Nov 24, 2021
REGARD Core Biopsy Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
REGARD Ultrasound Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…
Cordis Corporation
FDA Devices Critical Nov 24, 2021
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Scrip Inc
FDA Devices Critical Nov 24, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic…
Arrow International Inc
FDA Devices Moderate Nov 24, 2021
REGARD Stereotactic Tray
ROi CPS LLC
FDA Devices Moderate Nov 24, 2021
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…
Cordis Corporation
FDA Devices Moderate Nov 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Cook Inc.
FDA Devices Moderate Nov 24, 2021
API 50 CH, Model 50300
bioMerieux, Inc.
FDA Devices Critical Nov 24, 2021
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolyti…
Arrow International Inc
FDA Devices Moderate Nov 24, 2021
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Smith & Nephew, Inc.
FDA Devices Moderate Nov 24, 2021
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes …
Fujifilm Irvine Scientific, Inc.
FDA Devices Moderate Nov 17, 2021
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of t…
BioCheck, Inc.
FDA Devices Moderate Nov 17, 2021
Hemodialysis Delivery System, Software Version 2.x.
Baxter Healthcare Corporation
FDA Devices Moderate Nov 17, 2021
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Zhejiang Kindly Medical Devices Co., Ltd.
FDA Devices Moderate Nov 17, 2021
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
Zhejiang Kindly Medical Devices Co., Ltd.
FDA Devices Critical Nov 17, 2021
Ellume COVID-19 Home Test
ELLUME LTD
FDA Devices Moderate Nov 17, 2021
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 72222…
Philips North America Llc
FDA Devices Moderate Nov 17, 2021
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Therakos, Inc.
FDA Devices Moderate Nov 17, 2021
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Zhejiang Kindly Medical Devices Co., Ltd.
FDA Devices Moderate Nov 17, 2021
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
Zhejiang Kindly Medical Devices Co., Ltd.
FDA Devices Moderate Nov 17, 2021
McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Zhejiang Kindly Medical Devices Co., Ltd.
FDA Devices Moderate Nov 17, 2021
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Z-Medica, LLC
FDA Devices Moderate Nov 10, 2021
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydro…
Cook Inc.
FDA Devices Moderate Nov 10, 2021
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Karl Storz Endoscopy
FDA Devices Critical Nov 10, 2021
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L …
Lumenis, Inc.
FDA Devices Moderate Nov 10, 2021
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa
FDA Devices Moderate Nov 10, 2021
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Nov 10, 2021
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing LLC
FDA Devices Moderate Nov 10, 2021
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
FDA Devices Critical Nov 10, 2021
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience K…
Windstone Medical Packaging, Inc.
FDA Devices Moderate Nov 10, 2021
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
FDA Devices Moderate Nov 10, 2021
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Siemens Healthcare Diagnostics, Inc
FDA Devices Moderate Nov 10, 2021
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Nov 10, 2021
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing LLC
FDA Devices Moderate Nov 10, 2021
COVENA PICC Sleeve
Queen Comfort Products lLC
FDA Devices Moderate Nov 10, 2021
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the…
Bayer Medical Care, Inc.
FDA Devices Moderate Nov 10, 2021
Aspiration Syringe Kit, REF: MVSK60
MICROVENTION INC.