Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 166 of 548
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
CardioQuip, LLC
FDA Devices Moderate Oct 13, 2021
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capab…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated o…
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on …
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED…
ZOLL Circulation, Inc.
FDA Devices Critical Oct 13, 2021
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Aesthetics Systems Usa Inc
FDA Devices Moderate Oct 13, 2021
Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital r…
Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Oct 13, 2021
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital r…
Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Oct 13, 2021
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0…
Datascope Corp.
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage M…
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope …
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Medtronic Perfusion Systems
FDA Devices Moderate Oct 13, 2021
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile E…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-…
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Flower Orthopedics Corporation
FDA Devices Critical Oct 13, 2021
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
DJO, LLC
FDA Devices Moderate Oct 13, 2021
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
DePuy Orthopaedics, Inc.
FDA Devices Moderate Oct 13, 2021
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 l…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00…
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN …
ZOLL Circulation, Inc.
FDA Devices Moderate Oct 13, 2021
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-1…
Exactech, Inc.
FDA Devices Moderate Oct 13, 2021
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital r…
Paltop Advanced Dental Solutions Ltd
FDA Devices Moderate Oct 13, 2021
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED,…
ZOLL Circulation, Inc.
FDA Devices Critical Oct 13, 2021
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits,…
DJO, LLC
FDA Devices Moderate Oct 13, 2021
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
CardioQuip, LLC
FDA Devices Moderate Oct 6, 2021
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0m…
Corin Ltd
FDA Devices Moderate Oct 6, 2021
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
WOM World of Medicine AG
FDA Devices Moderate Oct 6, 2021
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0…
Datascope Corp.
FDA Devices Moderate Oct 6, 2021
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Corin Ltd
FDA Devices Moderate Oct 6, 2021
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT210…
Lymol Medical Corporation
FDA Devices Moderate Oct 6, 2021
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and po…
Deerfield Imaging, Inc.
FDA Devices Moderate Oct 6, 2021
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gel…
Vascutek, Ltd.
FDA Devices Moderate Oct 6, 2021
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) t…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA Devices Critical Oct 6, 2021
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, …
North Coast Medical Inc
FDA Devices Moderate Oct 6, 2021
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Corin Ltd
FDA Devices Moderate Oct 6, 2021
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmenta…
Atrium Medical Corporation
FDA Devices Moderate Oct 6, 2021
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
ConvaTec, Inc
FDA Devices Moderate Oct 6, 2021
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral flu…
B. Braun Medical, Inc.
FDA Devices Moderate Oct 6, 2021
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Olympus Corporation of the Americas
FDA Devices Moderate Oct 6, 2021
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Biodex Medical Systems, Inc.
FDA Devices Moderate Oct 6, 2021
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diag…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Oct 6, 2021
MOSAIQ Oncology Information System
Elekta, Inc.
FDA Devices Moderate Oct 6, 2021
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
Olympus Corporation of the Americas
FDA Devices Moderate Oct 6, 2021
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile;…
Medline Industries Inc