Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 182 of 548
FDA Devices Moderate May 5, 2021
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: …
Cardiac Assist, Inc
FDA Devices Moderate May 5, 2021
Scooter
Merits Holdings Co. dba Merits Health Products, Inc.
FDA Devices Moderate May 5, 2021
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation f…
Nextremity Solutions
FDA Devices Moderate May 5, 2021
Change Healthcare Enterprise Viewer
CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Moderate May 5, 2021
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Cytocell Ltd.
FDA Devices Moderate May 5, 2021
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open …
ConMed Corporation
FDA Devices Moderate May 5, 2021
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobili…
DJ Orthopedics de Mexico S.A. de C.V.
FDA Devices Moderate May 5, 2021
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Medical Solutions USA, Inc
FDA Devices Low May 5, 2021
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via th…
Datascope Corp.
FDA Devices Moderate May 5, 2021
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulatio…
Boston Scientific Corporation
FDA Devices Low May 5, 2021
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN…
Boston Scientific Corporation
FDA Devices Moderate May 5, 2021
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters a…
Smiths Medical ASD Inc.
FDA Devices Moderate May 5, 2021
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal …
Coltene Whaledent Inc
FDA Devices Moderate May 5, 2021
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the…
DJ Orthopedics de Mexico S.A. de C.V.
CPSC Moderate May 5, 2021
Peloton Recalls Tread Treadmills Due to Risk of Injury
CPSC Moderate May 5, 2021
Peloton Recalls Tread+ Treadmills After One Child Died and More than 70 Incidents Reported
CPSC Moderate May 5, 2021
Scott Fetzer Consumer Brands Recalls Multi-Use Water Pumps Due to Fire and Shock Hazards
Wayne/Scott Fetzer Company d/b/a Scott Fetzer Consumer Brands, of Harrison, Ohio
FDA Devices Moderate Apr 28, 2021
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1…
Heartware, Inc.
FDA Devices Moderate Apr 28, 2021
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various ty…
Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Apr 28, 2021
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 110…
Heartware, Inc.
FDA Devices Moderate Apr 28, 2021
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number M…
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model N…
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulat…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 28, 2021
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product…
Welch Allyn Inc Mortara
FDA Devices Moderate Apr 28, 2021
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricula…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
C.R. Bard, Inc.
FDA Devices Moderate Apr 28, 2021
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form …
Stryker Leibinger GmbH & Co. KG
FDA Devices Moderate Apr 28, 2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventr…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 mai…
Boston Scientific Corporation
FDA Devices Moderate Apr 28, 2021
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatri…
Welch Allyn Inc Mortara
FDA Devices Moderate Apr 28, 2021
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and vent…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid …
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Se…
Stryker Spine
FDA Devices Moderate Apr 28, 2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vasc…
Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Apr 28, 2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated…
Medtronic Sofamor Danek USA, Inc
FDA Devices Moderate Apr 28, 2021
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated…
Medtronic Sofamor Danek USA, Inc
FDA Devices Moderate Apr 28, 2021
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular de…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventric…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ve…
BIOTRONIK Inc
FDA Devices Moderate Apr 28, 2021
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of ext…
Smiths Medical ASD Inc.
FDA Devices Moderate Apr 28, 2021
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change,…
Trinity Sterile, Inc.
FDA Devices Moderate Apr 28, 2021
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…
BIOTRONIK Inc