Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 18 of 548
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…
Siemens Medical Solutions USA, Inc
FDA Devices Critical Oct 8, 2025
Biograph mMR. Model Number: 10433372.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT…
North American Rescue LLC.
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…
Northeast Scientific Inc.
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathe…
Northeast Scientific Inc.
FDA Devices Moderate Oct 8, 2025
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Man…
MedicalCommunications GmbH
FDA Devices Moderate Oct 8, 2025
ZAP-X Radiosurgery System, Model: 300150
Zap Surgical Systems
FDA Devices Critical Oct 8, 2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an an…
Draeger, Inc.
FDA Devices Critical Oct 8, 2025
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165…
Medline Industries, LP
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Aesculap AG
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…
Northeast Scientific Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Getinge Disinfection Ab
FDA Devices Moderate Oct 8, 2025
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Schiller, Ag
FDA Devices Critical Oct 8, 2025
MAGNETOM Verio. Model Number: 10276755.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Oct 8, 2025
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Medline Industries, LP
FDA Devices Critical Oct 8, 2025
MAGNETOM Lumina (DE). Model Number: 11344916.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Howmedica Osteonics Corp.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
Change Healthcare Radiology Solutions software version 14.2.2
CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Oct 8, 2025
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Siemens Medical Solutions USA, Inc
FDA Devices Critical Oct 8, 2025
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RR…
Medline Industries, LP
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Siemens Medical Solutions USA, Inc
FDA Devices Critical Oct 8, 2025
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medline Industries, LP
FDA Devices Critical Oct 8, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Siemens Medical Solutions USA, Inc
FDA Devices Critical Oct 8, 2025
MAGNETOM Vida Fit. Model Number: 11410481.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathe…
Northeast Scientific Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Oct 8, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Oct 8, 2025
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an …
Draeger, Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9…
LeMaitre Vascular, Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, sof…
bioMerieux, Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Ca…
Northeast Scientific Inc.
FDA Devices Critical Oct 8, 2025
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Medline Industries, LP
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Oct 8, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…
Northeast Scientific Inc.
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Oct 8, 2025
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectom…
Northeast Scientific Inc.
FDA Devices Critical Oct 8, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Siemens Medical Solutions USA, Inc
FDA Devices Critical Oct 8, 2025
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Me…
Medline Industries, LP