Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,606 total recalls
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Abbott Medical
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
DeRoyal Industries Inc
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50
Megadyne Medical Products, Inc.
HVI CARDIAC ROBOT PACK. Medical convenience kit.
AVID Medical, Inc.
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI
Changchun Wancheng Bio-Electron Co., Ltd.
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-
MEDLINE INDUSTRIES, LP - Northfield
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument T
Trackx Technology Inc
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Medline Industries, LP
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Diversatek Healthcare
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Appliedvr
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
CooperSurgical, Inc.
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear th
Synthes (USA) Products LLC
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
Mckesson Medical-Surgical Inc. Corporate Office
UROSKOP Omnia. Model Number: 10094910
Siemens Medical Solutions USA, Inc
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
American Contract Systems Inc.
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline E
Defibtech, LLC
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Deroyal Industries, Inc. Lafollette
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
3M Healthcare Business
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Olympus Corporation of the Americas
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83
MEDLINE INDUSTRIES, LP - Northfield
Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Shar
MEDLINE INDUSTRIES, LP - Northfield
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection
C.R. Bard Inc
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Medtronic MiniMed, Inc.
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transderm
LTS Therapy Systems, LLC
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Siemens Healthcare Diagnostics Inc
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa
Zyno Medical LLC
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Waldemar Link GmbH & Co. KG (Mfg Site)
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Karl Storz Endoscopy
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Boston Scientific Corporation
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