Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 193 of 548
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species lev…
Beckman Coulter Inc.
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 CX 90¿ Cryoablation Needle¿
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Five IceSphere" Prostate Cryoablation Kit
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
GE Healthcare, LLC
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hang…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system wh…
Integra LifeSciences Corp.
FDA Devices Moderate Dec 30, 2020
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…
B Braun Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
GA HEALTH COMPANY LIMITED
FDA Devices Moderate Dec 30, 2020
Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used…
Zimmer Biomet, Inc.
FDA Devices Moderate Dec 30, 2020
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
GE Healthcare, LLC
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge …
Hardy Diagnostics
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 i-Thaw" Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, S…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Biomet, Inc.
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl tr…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 MRI Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Nova Ortho-Med Inc
FDA Devices Moderate Dec 30, 2020
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN …
GA HEALTH COMPANY LIMITED
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 CX 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
ICU Medical, Inc.
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 S 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl trans…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Dec 30, 2020
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
ConMed Corporation
FDA Devices Moderate Dec 30, 2020
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
ConMed Corporation
FDA Devices Moderate Dec 30, 2020
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Cla…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Critical Dec 30, 2020
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding S…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouc…
CryoLife, Inc.
FDA Devices Moderate Dec 30, 2020
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patien…
B Braun Medical, 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 Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
ICU Medical, Inc.
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CS…
Integra LifeSciences Corp.
FDA Devices Moderate Dec 30, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fl…
Baxter Healthcare Corporation
FDA Devices Moderate Dec 30, 2020
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Ap…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Baxter Healthcare Corporation
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduc…
Cook Inc.
FDA Devices Moderate Dec 30, 2020
Five IceRod" i-Thaw" Prostate Cryoablation Kit
Boston Scientific Corporation