RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,640 total recalls

Artis Q ceiling, Model Number 10848281

Siemens Medical Solutions USA, Inc

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement with

Stryker Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROB

MEDLINE INDUSTRIES, LP - Northfield

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46

Linkbio Corp.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT

MEDLINE INDUSTRIES, LP - Northfield

Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE

Medline Industries, LP

Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

MEDLINE INDUSTRIES, LP - Northfield

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12

DeVilbiss Healthcare LLC

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie M

Siemens Medical Solutions USA, Inc

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

DxM 1096 MicroScan WalkAway Instrument REF B1018-496

Beckman Coulter Inc.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22

Merit Medical Systems, Inc.

Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Woodside Acquisitions Inc.

L9-3 Transducer Probe

Philips Ultrasound, Inc

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call

Hill-Rom Inc.

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

SEDECAL SA

Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Gentuity, LLC

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Stradis Healthcare

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Beckman Coulter, Inc.

MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v

Angiodynamics, Inc.

MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C

MEDLINE INDUSTRIES, LP - Northfield

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Medtronic Xomed, Inc.

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Fresenius Medical Care Renal Therapies Group, LLC

Philips Azurion system; Software Version Number: R3.1;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Cascade IOMAX Cortical Module, REF: 190296-200

Cadwell Industries Inc

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M

Merit Medical Systems, Inc.

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