Browse recalls
Alert level: Class II
- 2025-09-12 · US FDA — Medical DevicesClass II
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-08 · US FDA — Medical DevicesClass II
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU - 2025-09-05 · US FDA — Medical DevicesClass II
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; M - 2025-09-05 · US FDA — Medical DevicesClass II
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0 - 2025-09-05 · US FDA — Medical DevicesClass II
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M - 2025-09-05 · US FDA — Medical DevicesClass II
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1 - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17 - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits IHDC30R D AND C PACK - 2025-09-04 · US FDA — Medical DevicesClass II
Basic Biopsy Tray, Item Number NMBP44L - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15 - 2025-09-04 · US FDA — Medical DevicesClass II
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329 - 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 - 2025-08-27 · 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 - 2025-08-19 · 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 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 - 2025-07-29 · US FDA — Medical DevicesClass II
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a - 2025-07-25 · US FDA — Medical DevicesClass II
ZAP-X Radiosurgery System, Model: 300150 - 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 II
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers - 2025-07-23 · US FDA — Medical DevicesClass II
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH - 2025-07-17 · 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 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 - 2025-07-08 · 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. - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 - 2025-06-20 · US FDA — Medical DevicesClass II
GE Signa Artist, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System