Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Orthopediatrics Corp
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilizatio...
Medical Devices·73 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow di...
Medical Devices·350,779 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system int...
Medical Devices·8 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow d...
Medical Devices·27,341 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracte...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Golden Technologies, Inc.
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising f...
Medical Devices·251 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Boston Scientific Corporation
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Arrow International Inc
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly t...
Medical Devices·0 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clam...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow dire...
Medical Devices·29,740 affected·Jul 6, 2020
High RiskFDA
Teleflex Medical Inc
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the...
Medical Devices·1,812 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Medical Devices·310,969 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Medical Devices·824,277 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Medical Devices·824,277 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming ...
Medical Devices·130,612 affected·Jun 30, 2020
High RiskFDA
Hill-rom, Inc.
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated wit...
Medical Devices·257 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Medical Devices·1,332,354 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100
Medical Devices·1,093,588 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices·38,982 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Medical Devices·152,539 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Medical Devices·17,767 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Medical Devices·7,854 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of ...
Medical Devices·1,442,097 affected·Jun 30, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Medical Devices·1,800 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the ...
Medical Devices·8,558 affected·Jun 30, 2020
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software
Medical Devices·146,224 affected·Jun 30, 2020
High RiskFDA
Philips North America, Llc
IntelliVue MX800 patient monitor, model no. 865240
Medical Devices·28 affected·Jun 30, 2020
CriticalFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Medical Devices·37,141 affected·Jun 30, 2020
High RiskFDA
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patien...
Medical Devices·3 affected·Jun 29, 2020
High RiskFDA
Boss Instruments, Ltd.
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are s...
Medical Devices·96 affected·Jun 26, 2020
High RiskFDA
Covidien Llc
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp style...
Medical Devices·269 affected·Jun 26, 2020
High RiskFDA
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to hel...
Medical Devices·12 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
SUTUREFIX ULTRA Suture, Product number 72203855
Medical Devices·868 affected·Jun 24, 2020
High RiskFDA
Arthrex, Inc.
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...
Medical Devices·28 affected·Jun 24, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Medical Devices·8 affected·Jun 23, 2020
High RiskFDA
Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Medical Devices·0 affected·Jun 23, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to...
Medical Devices·8,414 affected·Jun 22, 2020
High RiskFDA
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 21319...
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Medical Devices·5,296,132 affected·Jun 19, 2020
High RiskFDA
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00...
Medical Devices·5,296,132 affected·Jun 19, 2020