Browse recalls
Issuing authority: US FDA — Medical Devices
- 2024-01-08 · US FDA — Medical DevicesClass II
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t - 2024-01-08 · US FDA — Medical DevicesClass II
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632 - 2024-01-08 · US FDA — Medical DevicesClass II
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672 - 2024-01-08 · US FDA — Medical DevicesClass II
BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664 - 2024-01-04 · US FDA — Medical DevicesClass II
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe - 2024-01-03 · US FDA — Medical DevicesClass II
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. - 2024-01-03 · US FDA — Medical DevicesClass II
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 - 2024-01-03 · US FDA — Medical DevicesClass II
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. - 2024-01-03 · US FDA — Medical DevicesClass II
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. - 2024-01-03 · US FDA — Medical DevicesClass II
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. - 2024-01-03 · US FDA — Medical DevicesClass II
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces - 2024-01-03 · US FDA — Medical DevicesClass II
Achieva XR. Model (REF) Numbers 781153, 781253. - 2024-01-03 · US FDA — Medical DevicesClass II
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images. - 2024-01-03 · US FDA — Medical DevicesClass II
Achieva 1.5T Initial system. Model (REF) Numbers 781178. - 2024-01-02 · US FDA — Medical DevicesClass II
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected - 2024-01-02 · US FDA — Medical DevicesClass II
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected - 2023-12-29 · US FDA — Medical DevicesClass I
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 - 2023-12-29 · US FDA — Medical DevicesClass III
Achieva 3.0T, Model No. 781177 - 2023-12-29 · US FDA — Medical DevicesClass III
SmartPath to dStream for 1.5T, Model No. 781260, 782112 - 2023-12-29 · US FDA — Medical DevicesClass III
Intera 1.5T, Model No. 781195 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777 - 2023-12-28 · US FDA — Medical DevicesClass I
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000 - 2023-12-26 · US FDA — Medical DevicesClass II
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 - 2023-12-26 · US FDA — Medical DevicesClass I
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 - 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 I
smiths medical Medfusion Model 3500 Syringe pump - 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 I
smiths medical Medfusion Model 4000 syringe pump - 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 I
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4 - 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 - 2023-12-15 · US FDA — Medical DevicesClass I
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074 - 2023-12-15 · US FDA — Medical DevicesClass I
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292 - 2023-12-13 · US FDA — Medical DevicesClass I
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit - 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 - 2023-12-08 · US FDA — Medical DevicesClass I
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M - 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 — 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 I
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap - 2023-11-30 · US FDA — Medical DevicesClass II
BrightView X, Gamma Camera, Product Code 882478 - 2023-11-30 · US FDA — Medical DevicesClass I
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE - 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 I
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 - 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 - 2023-11-20 · US FDA — Medical DevicesClass I
AirTouch F20 Full Face Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirTouch N20 Nasal Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirFit F30 Full Face Mask and User Guide - 2023-11-20 · US FDA — Medical DevicesClass I
AirFit N10 Nasal Masks and User Guide