Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 204 of 548
FDA Devices Moderate Sep 23, 2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn tre…
Integra LifeSciences Corp.
FDA Devices Moderate Sep 23, 2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand …
Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Sep 23, 2020
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabi…
LONGHORN VACCINES AND DIAGNOSTIC
FDA Devices Moderate Sep 23, 2020
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and dat…
Novarad Corporation
FDA Devices Moderate Sep 23, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES, LTD.
FDA Devices Moderate Sep 16, 2020
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUT…
MicroPort Orthopedics Inc.
FDA Devices Critical Sep 16, 2020
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusio…
CareFusion 303, Inc.
FDA Devices Moderate Sep 16, 2020
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the…
Hager & Meisinger Gmbh
FDA Devices Moderate Sep 16, 2020
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or…
Smith & Nephew, Inc.
FDA Devices Critical Sep 16, 2020
Alaris System PC Unit Model 8015
CareFusion 303, Inc.
FDA Devices Moderate Sep 16, 2020
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usa…
Talladium Inc
FDA Devices Critical Sep 16, 2020
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Re…
CareFusion 303, Inc.
FDA Devices Moderate Sep 16, 2020
SICAT IMPLANT V2.0
SICAT GMBH & CO. KG
FDA Devices Moderate Sep 16, 2020
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…
Qiagen Sciences LLC
FDA Devices Moderate Sep 16, 2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Intuitive Surgical, Inc.
FDA Devices Moderate Sep 16, 2020
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Medical Components, Inc dba MedComp
FDA Devices Moderate Sep 9, 2020
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures.…
Ge Healthcare
FDA Devices Moderate Sep 9, 2020
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the …
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeuti…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
RANDOX LABORATORIES, LTD.
FDA Devices Moderate Sep 9, 2020
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Diasorin Inc.
FDA Devices Moderate Sep 9, 2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Exactech, Inc.
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimul…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac trop…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 9, 2020
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antise…
Remel Europe Ltd.
FDA Devices Moderate Sep 9, 2020
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheteriza…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Brainlab AG
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulati…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulatio…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional i…
CareFusion 303, Inc.
FDA Devices Moderate Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
FDA Devices Moderate Sep 9, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic…
Stimwave Technologies Inc
FDA Devices Moderate Sep 9, 2020
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment t…
TELEFLEX MEDICAL INC
CPSC Moderate Sep 9, 2020
WHILL Recalls WHILL Personal Electric Vehicles Due to Crash and Injury Hazards
WHILL, Inc. (Japan), of Japan
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0…
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…
Karl Storz Endoscopy
FDA Devices Moderate Sep 2, 2020
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and v…
Karl Storz Endoscopy
FDA Devices Moderate Sep 2, 2020
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: …
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Globus Medical, Inc.
FDA Devices Moderate Sep 2, 2020
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and sta…
Neurovision Medical Products Inc
FDA Devices Moderate Sep 2, 2020
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac …
Datascope Corporation
FDA Devices Moderate Sep 2, 2020
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Prod…
Ortho-Clinical Diagnostics
FDA Devices Moderate Sep 2, 2020
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electroph…
Biosense Webster (israel), Ltd.