Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,583 total recalls
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
vRad PACS with Mammography
Virtual Radiologic Corp.
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Cordis Corporation
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi
B Braun Medical Inc
Mojo 2 Full Face Non Vented Mask, All Sizes
SleepNet Corporation
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
MEDLINE INDUSTRIES, LP - Northfield
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software
Olympus Corporation of the Americas
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
ADRIA SRL
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
DeRoyal Industries Inc
OMTech Desktop Laser Engraver
Rygel Advanced Machines d/b/a Omtech Laser
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Boston Scientific Neuromodulation Corporation
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0
Howmedica Osteonics Corp.
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI
MEDLINE INDUSTRIES, LP - Northfield
DENTEMP ONE STEP .077OZ, SKU 902139
Family Dollar Stores, Llc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed i
ICU Medical, Inc.
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCR
Entopsis , Inc.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging, Inc.
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PU
MEDLINE INDUSTRIES, LP - Northfield
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v
Datex-Ohmeda, Inc.
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
MEDLINE INDUSTRIES, LP - Northfield
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller
Abiomed, Inc.
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle,
Bard Peripheral Vascular Inc
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Abbott
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medi
Wondfo USA Co Ltd
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Aesculap Implant Systems LLC
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and sta
Zimmer, Inc.
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Medline Industries, LP
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