Browse recalls
Alert level: Class II
- 2023-12-26 · US FDA — Medical DevicesClass II
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 - 2023-12-22 · US FDA — Medical DevicesClass II
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis - 2023-12-21 · US FDA — Medical DevicesClass II
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888 - 2023-12-21 · US FDA — Medical DevicesClass II
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 - 2023-12-21 · US FDA — Medical DevicesClass II
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C - 2023-12-21 · US FDA — Medical DevicesClass II
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A - 2023-12-21 · US FDA — Medical DevicesClass II
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A - 2023-12-21 · US FDA — Medical DevicesClass II
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A - 2023-12-20 · US FDA — Medical DevicesClass II
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and - 2023-12-19 · US FDA — Medical DevicesClass II
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5 - 2023-12-19 · US FDA — Medical DevicesClass II
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 - 2023-12-19 · US FDA — Medical DevicesClass II
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a - 2023-12-19 · US FDA — Medical DevicesClass II
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0 - 2023-12-18 · US FDA — Medical DevicesClass II
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile. - 2023-12-18 · US FDA — Medical DevicesClass II
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 - 2023-12-15 · US FDA — Medical DevicesClass II
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 - 2023-12-15 · US FDA — Medical DevicesClass II
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150 - 2023-12-15 · US FDA — Medical DevicesClass II
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 - 2023-12-12 · US FDA — Medical DevicesClass II
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged. - 2023-12-11 · US FDA — Medical DevicesClass II
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte - 2023-12-08 · US FDA — Medical DevicesClass II
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olym - 2023-12-07 · US FDA — Medical DevicesClass II
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 - 2023-12-07 · US FDA — Medical DevicesClass II
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro - 2023-12-05 · US FDA — Medical DevicesClass II
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 - 2023-12-04 · US FDA — Medical DevicesClass II
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-A - 2023-12-01 · US FDA — FoodClass II
Pamana Premium Marinated Bangus (Deboned Marinated Milkfish), Net Weight to be Weight at Time of Sale - 2023-12-01 · US FDA — FoodClass II
Pamana Premium Marinated Baby Bangus (Deboned Marinated Baby Milkfish), Net Weight to be Weight at Time of Sale - 2023-12-01 · US FDA — FoodClass II
Pamana Premium Bangus Belly (Cut Deboned Milkfish Belly), 340 g (120 oz) - 2023-12-01 · US FDA — Medical DevicesClass II
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . - 2023-12-01 · US FDA — Medical DevicesClass II
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX - 2023-11-30 · US FDA — Medical DevicesClass II
BrightView X, Gamma Camera, Product Code 882478 - 2023-11-30 · US FDA — Medical DevicesClass II
BrightView, Gamma Camera System, Product Code 882480. - 2023-11-30 · US FDA — Medical DevicesClass II
BrightView XCT, Gamma Camera, Product Code 882482 - 2023-11-29 · US FDA — Medical DevicesClass II
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGT - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21 - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; - 2023-11-29 · US FDA — Medical DevicesClass II
RX Series Copper (Cu) Assay Ref. Number CU2340 - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; - 2023-11-29 · US FDA — Medical DevicesClass II
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit - 2023-11-28 · US FDA — Medical DevicesClass II
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controll - 2023-11-28 · US FDA — Medical DevicesClass II
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 - 2023-11-28 · US FDA — Medical DevicesClass II
VADER pedicle system, torque wrench, Catalog Number 42-702 - 2023-11-28 · US FDA — Medical DevicesClass II
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. - 2023-11-28 · US FDA — Medical DevicesClass II
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. - 2023-11-28 · US FDA — Medical DevicesClass II
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 - 2023-11-27 · US FDA — Medical DevicesClass II
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE - 2023-11-21 · US FDA — Medical DevicesClass II
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 - 2023-11-21 · US FDA — Medical DevicesClass II
QMS Tacrolimus Calibrators, Product code 10015573 - 2023-11-15 · US FDA — Medical DevicesClass II
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 - 2023-11-15 · US FDA — Medical DevicesClass II
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A - 2023-11-15 · US FDA — Medical DevicesClass II
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional - 2023-11-14 · US FDA — Medical DevicesClass II
BD Recanalization System, REF: BDRECANSYSTEM - 2023-11-13 · US FDA — Medical DevicesClass II
Medtronic SynchroMed II, Model 8637-20, Programmable pump - 2023-11-13 · US FDA — Medical DevicesClass II
Medtronic SynchroMed II, Model 8637-40, Programmable pump - 2023-11-13 · US FDA — Medical DevicesClass II
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an - 2023-11-10 · US FDA — Medical DevicesClass II
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R - 2023-11-10 · US FDA — Medical DevicesClass II
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R - 2023-11-10 · US FDA — Medical DevicesClass II
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL - 2023-11-10 · US FDA — Medical DevicesClass II
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte - 2023-11-07 · US FDA — Medical DevicesClass II
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp - 2023-11-07 · US FDA — Medical DevicesClass II
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the - 2023-11-07 · US FDA — Medical DevicesClass II
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator - 2023-11-07 · US FDA — Medical DevicesClass II
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca - 2023-11-06 · US FDA — Medical DevicesClass II
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree - 2023-11-01 · US FDA — Medical DevicesClass II
Atrium Oasis Drain Single W / AC, Part No. 3600-100 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 - 2023-10-31 · US FDA — Medical DevicesClass II
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP - 2023-10-31 · US FDA — Medical DevicesClass II
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 - 2023-10-26 · US FDA — Medical DevicesClass II
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to - 2023-10-26 · US FDA — Medical DevicesClass II
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear - 2023-10-25 · US FDA — Medical DevicesClass II
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear - 2023-10-25 · US FDA — Medical DevicesClass II
CD11b APC: ASR, REF: 340936, and CE, REF: 333143