FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 18 of 520
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.
Critical Oct 8, 2025
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Medline Industries, LP
Critical Oct 8, 2025
MAGNETOM Lumina (DE). Model Number: 11344916.
Siemens Medical Solutions USA, Inc
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.
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.
Moderate Oct 8, 2025
Change Healthcare Radiology Solutions software version 14.2.2
CHANGE HEALTHCARE CANADA COMPANY
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.
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
Critical Oct 8, 2025
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RR…
Medline Industries, LP
Critical Oct 8, 2025
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Siemens Medical Solutions USA, Inc
Critical Oct 8, 2025
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medline Industries, LP
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
Critical Oct 8, 2025
MAGNETOM Vida Fit. Model Number: 11410481.
Siemens Medical Solutions USA, Inc
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.
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.
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.
Critical Oct 8, 2025
MAGNETOM Skyra fit. Model Number: 10849580.
Siemens Medical Solutions USA, Inc
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Critical Oct 8, 2025
MAGNETOM Cima.X (DE). Model Number: 11647158.
Siemens Medical Solutions USA, Inc
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.
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.
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.
Critical Oct 8, 2025
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Siemens Medical Solutions USA, Inc
Critical Oct 8, 2025
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Me…
Medline Industries, LP
Moderate Oct 8, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Anal…
Beckman Coulter Inc.
Moderate Oct 8, 2025
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF…
S.I.N. Implant System Ltda
Moderate Oct 8, 2025
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 1, 2025
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; …
Baxter Healthcare Corporation
Moderate Oct 1, 2025
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Tandem Diabetes Care, Inc.
Moderate Oct 1, 2025
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K1628…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 1, 2025
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 1, 2025
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Oct 1, 2025
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Oct 1, 2025
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Oct 1, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-60…
Maquet Cardiovascular, LLC
Moderate Oct 1, 2025
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Oct 1, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Produ…
Abiomed, Inc.
Moderate Oct 1, 2025
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Stryker Communications
Moderate Oct 1, 2025
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Philips North America Llc
Moderate Oct 1, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.