Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 207 of 548
FDA Devices Moderate Aug 12, 2020
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-par…
GE Healthcare, LLC
FDA Devices Moderate Aug 12, 2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.…
Covidien Llc
FDA Devices Moderate Aug 12, 2020
SUTUREFIX ULTRA Suture, Product number 72203855
Smith & Nephew, Inc.
FDA Devices Moderate Aug 12, 2020
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Mako Surgical Corporation
FDA Devices Moderate Aug 12, 2020
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
Siemens Medical Solutions USA, Inc
FDA Devices Critical Aug 12, 2020
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Critical Aug 12, 2020
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Aug 12, 2020
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Aug 12, 2020
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexib…
Boston Scientific Corporation
FDA Devices Critical Aug 12, 2020
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Critical Aug 12, 2020
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Moderate Aug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determ…
RANDOX LABORATORIES, LTD.
CPSC Moderate Aug 12, 2020
Intertex Recalls Blowers Due To Fire Hazard
FDA Food Moderate Aug 5, 2020
Kasugai brand Matcha Ame (Green tea candy); 4.58 oz. plastic bag; 2 x 12 individual items per case Product of Japan Ingredients: glucose syrup, …
J F C International Inc
FDA Devices Moderate Aug 5, 2020
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
FDA Devices Moderate Aug 5, 2020
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver …
Ion Beam Applications S.A.
FDA Devices Moderate Aug 5, 2020
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the pos…
OrthoPediatrics Corp
FDA Devices Moderate Aug 5, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomic…
Medtronic Navigation, Inc.
FDA Devices Moderate Aug 5, 2020
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
FDA Devices Moderate Aug 5, 2020
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility…
Hill-Rom, Inc.
FDA Devices Moderate Aug 5, 2020
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as cran…
Synthes Produktions GmbH
FDA Devices Moderate Aug 5, 2020
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of t…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Aug 5, 2020
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visual…
TELEFLEX MEDICAL INC
FDA Devices Moderate Aug 5, 2020
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for end…
Medline Industries Inc
FDA Devices Moderate Aug 5, 2020
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designe…
Richard Wolf GmbH
FDA Devices Moderate Aug 5, 2020
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
FDA Devices Moderate Aug 5, 2020
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedu…
Smith & Nephew, Inc.
FDA Devices Moderate Aug 5, 2020
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemicall…
Resource Optimization & Innovation LLC
FDA Devices Moderate Aug 5, 2020
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or i…
Arthrex, Inc.
FDA Devices Moderate Aug 5, 2020
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of t…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Aug 5, 2020
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualiza…
TELEFLEX MEDICAL INC
FDA Devices Moderate Aug 5, 2020
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as cranio…
Synthes, Inc.
FDA Devices Moderate Aug 5, 2020
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Abbott Gmbh & Co. KG
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablatio…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 0080…
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended f…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343…
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG …
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
FDA Devices Moderate Jul 29, 2020
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505)…
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA0…
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231)…
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jul 29, 2020
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the s…
Smith & Nephew, Inc.
FDA Devices Moderate Jul 29, 2020
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI …
Becton Dickinson & Company
FDA Devices Moderate Jul 29, 2020
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
U&I CORP.
FDA Devices Moderate Jul 29, 2020
Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
Carefusion 2200 Inc