RecallHawk

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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