Browse recalls
Issuing authority: US FDA — Medical Devices
- 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 - 2025-09-03 · US FDA — Medical DevicesClass II
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic - 2025-09-02 · US FDA — Medical DevicesClass II
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configurati - 2025-08-29 · US FDA — Medical DevicesClass II
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emissi - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1 - 2025-08-28 · US FDA — Medical DevicesClass I
Biograph mMR. Model Number: 10433372. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Verio. Model Number: 10276755. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Lumina (DE). Model Number: 11344916. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Vida Fit. Model Number: 11410481. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra fit. Model Number: 10849580. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Cima.X (DE). Model Number: 11647158. - 2025-08-28 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Verio Dot Upgrade. Model Number: 10684334. - 2025-08-27 · US FDA — Medical DevicesClass II
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position - 2025-08-26 · US FDA — Medical DevicesClass II
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. - 2025-08-26 · US FDA — Medical DevicesClass II
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. - 2025-08-22 · US FDA — Medical DevicesClass II
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L211 PROPONENT DR SL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number S702, ALTRUA 2 DR SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U128, VALITUDE CRT-P EL MRI - 2025-08-20 · US FDA — Medical DevicesClass I
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L231, PROPONENT DR EL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L101, ESSENTIO DR SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L209 PROPONENT DR (VDD) SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U226, VISIONIST CRT-P EL - 2025-08-20 · US FDA — Medical DevicesClass I
PROPONENT SR SL (Model L200) - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U228, VISIONIST CRT-P EL MRI - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L221 PROPONENT DR EL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L131, ESSENTIO DR EL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
ACCOLADE DR EL MRI (Model L331) - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L121 ESSENTIO DR EL Pacemaker - 2025-08-19 · US FDA — Medical DevicesClass II
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc - 2025-08-13 · US FDA — Medical DevicesClass II
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software - 2025-08-11 · US FDA — Medical DevicesClass II
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M - 2025-08-06 · US FDA — Medical DevicesClass II
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel H - 2025-08-06 · US FDA — Medical DevicesClass II
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System - 2025-08-05 · US FDA — Medical DevicesClass II
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology) - 2025-08-05 · US FDA — Medical DevicesClass II
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a - 2025-08-05 · US FDA — Medical DevicesClass II
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. - 2025-08-04 · US FDA — Medical DevicesClass II
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, - 2025-08-04 · US FDA — Medical DevicesClass I
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump - 2025-08-04 · US FDA — Medical DevicesClass I
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump - 2025-08-04 · US FDA — Medical DevicesClass II
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part - 2025-07-31 · US FDA — Medical DevicesClass II
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606 - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass II
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal - 2025-07-25 · US FDA — Medical DevicesClass II
ZAP-X Radiosurgery System, Model: 300150 - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe - 2025-07-24 · US FDA — Medical DevicesClass II
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N - 2025-07-24 · US FDA — Medical DevicesClass II
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe - 2025-07-23 · US FDA — Medical DevicesClass II
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH - 2025-07-21 · US FDA — Medical DevicesClass I
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen - 2025-07-17 · US FDA — Medical DevicesClass II
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A - 2025-07-17 · US FDA — Medical DevicesClass II
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A - 2025-07-16 · US FDA — Medical DevicesClass II
Pentax Medical Video Processor; Model Number: EPK-i8020c; - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4 - 2025-07-14 · US FDA — Medical DevicesClass II
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F - 2025-07-14 · US FDA — Medical DevicesClass I
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLB - 2025-07-14 · US FDA — Medical DevicesClass II
Spectrum IQ Infusion Pump, Product Code 3570009 - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NU - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANC - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; - 2025-07-14 · US FDA — Medical DevicesClass II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61 - 2025-07-10 · US FDA — Medical DevicesClass I
IDM-MICRO-R. Electrical wheelchair component. - 2025-07-10 · US FDA — Medical DevicesClass I
Micro Joystick R-net. Electrical wheelchair component. - 2025-07-09 · US FDA — Medical DevicesClass I
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. - 2025-07-08 · US FDA — Medical DevicesClass II
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili - 2025-07-08 · US FDA — Medical DevicesClass II
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu - 2025-07-08 · US FDA — Medical DevicesClass II
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 - 2025-07-07 · US FDA — Medical DevicesClass II
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. - 2025-07-02 · US FDA — Medical DevicesClass II
GE HealthCare OEC 9900 Elite C-arm Systems. - 2025-07-02 · US FDA — Medical DevicesClass II
GE HealthCare OEC 9800. - 2025-06-30 · US FDA — Medical DevicesClass II
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. - 2025-06-30 · US FDA — Medical DevicesClass II
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000. - 2025-06-26 · US FDA — Medical DevicesClass II
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, - 2025-06-26 · US FDA — Medical DevicesClass II
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. - 2025-06-26 · US FDA — Medical DevicesClass I
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457