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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