Browse recalls
Alert level: Class II
- 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac - 2023-10-19 · US FDA — Medical DevicesClass II
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX) - 2023-10-17 · US FDA — Medical DevicesClass II
Lugol s Iodine Solution 500ML, Part Number 624-71 - 2023-10-17 · US FDA — Medical DevicesClass II
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In - 2023-10-16 · US FDA — Medical DevicesClass II
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-16 · US FDA — Medical DevicesClass II
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-16 · US FDA — Medical DevicesClass II
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-12 · US FDA — Medical DevicesClass II
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 - 2023-10-11 · US FDA — Medical DevicesClass II
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, re - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 - 2023-10-09 · US FDA — Medical DevicesClass II
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 - 2023-10-09 · US FDA — Medical DevicesClass II
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati - 2023-10-09 · US FDA — Medical DevicesClass II
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo - 2023-10-09 · US FDA — Medical DevicesClass II
MED-810A Zemits NDPrime Laser products - 2023-10-06 · US FDA — Medical DevicesClass II
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation - 2023-10-05 · US FDA — Medical DevicesClass II
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK - 2023-10-04 · US FDA — Medical DevicesClass II
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 - 2023-10-02 · US FDA — Medical DevicesClass II
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology - 2023-10-02 · US FDA — Medical DevicesClass II
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. - 2023-09-29 · US FDA — Medical DevicesClass II
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500 - 2023-09-29 · US FDA — Medical DevicesClass II
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 - 2023-09-29 · US FDA — Medical DevicesClass II
IRON assay, Reference Numbers 6K95-41 and 6K95-30 - 2023-09-27 · US FDA — Medical DevicesClass II
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix - 2023-09-26 · US FDA — Medical DevicesClass II
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. - 2023-09-26 · US FDA — Medical DevicesClass II
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN - 2023-09-26 · US FDA — Medical DevicesClass II
RAPIDPOINT 500 Blood Gas System - 2023-09-26 · US FDA — Medical DevicesClass II
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium- - 2023-09-25 · US FDA — Medical DevicesClass II
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an - 2023-09-25 · US FDA — Medical DevicesClass II
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial i - 2023-09-25 · US FDA — Medical DevicesClass II
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper - 2023-09-25 · US FDA — Medical DevicesClass II
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15 - 2023-09-25 · US FDA — Medical DevicesClass II
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary - 2023-09-25 · US FDA — Medical DevicesClass II
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il - 2023-09-25 · US FDA — Medical DevicesClass II
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endosc - 2023-09-25 · US FDA — Medical DevicesClass II
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and - 2023-09-25 · US FDA — Medical DevicesClass II
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF- - 2023-09-25 · US FDA — Medical DevicesClass II
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V - 2023-09-25 · US FDA — Medical DevicesClass II
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch - 2023-09-25 · US FDA — Medical DevicesClass II
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. - 2023-09-25 · US FDA — Medical DevicesClass II
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du - 2023-09-25 · US FDA — Medical DevicesClass II
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en - 2023-09-21 · US FDA — Medical DevicesClass II
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit - 2023-09-21 · US FDA — Medical DevicesClass II
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 - 2023-09-19 · US FDA — Medical DevicesClass II
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le - 2023-09-18 · US FDA — Medical DevicesClass II
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, - 2023-09-18 · US FDA — Medical DevicesClass II
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an - 2023-09-15 · US FDA — FoodClass II
Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case, Perishable Keep Refrigerated - 2023-09-14 · US FDA — Medical DevicesClass II
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System - 2023-09-14 · US FDA — Medical DevicesClass II
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System - 2023-09-13 · US FDA — FoodClass II
Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g), plastic package (i.e.) Clamp shell, 8 package per case, Fro - 2023-09-12 · US FDA — Medical DevicesClass II
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains - 2023-09-12 · US FDA — Medical DevicesClass II
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic - 2023-09-12 · US FDA — Medical DevicesClass II
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w - 2023-09-07 · US FDA — Medical DevicesClass II
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 - 2023-09-06 · US FDA — Medical DevicesClass II
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 - 2023-09-06 · US FDA — Medical DevicesClass II
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) - 2023-09-01 · US FDA — Medical DevicesClass II
LAVH, REF BBLV21C - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack SAH, REF SAR530M - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack, REF SJVO56B - 2023-09-01 · US FDA — Medical DevicesClass II
Vasc. Open CVOR SJH, REF SJVO56B - 2023-09-01 · US FDA — Medical DevicesClass II
CVS PCSU SJH, REF SJCV48J - 2023-09-01 · US FDA — Medical DevicesClass II
Pediatric Heart SJH, REF SJPH34K - 2023-09-01 · US FDA — Medical DevicesClass II
Cath Cardiac Pack, REF IHCC03V - 2023-09-01 · US FDA — Medical DevicesClass II
Robotics Pack, REF SSRO22D - 2023-09-01 · US FDA — Medical DevicesClass II
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mic - 2023-09-01 · US FDA — Medical DevicesClass II
Sub Q Recorder Pack, REF BPRC87A - 2023-08-31 · US FDA — Medical DevicesClass II
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 - 2023-08-31 · US FDA — Medical DevicesClass II
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 - 2023-08-30 · US FDA — Medical DevicesClass II
Citrine Triple Quad Mass Spectrometer, Part Number 5063684 - 2023-08-30 · US FDA — Medical DevicesClass II
4500MD Triple Quad Mass Spectrometer, Part Number 5032522 - 2023-08-30 · US FDA — Medical DevicesClass II
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct - 2023-08-25 · US FDA — Medical DevicesClass II
Multichem P, Part Code 08P90-10 - 2023-08-25 · US FDA — Medical DevicesClass II
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 - 2023-08-24 · US FDA — Medical DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used Wit - 2023-08-23 · US FDA — Medical DevicesClass II
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au - 2023-08-23 · US FDA — Medical DevicesClass II
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 serie - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam ster - 2023-08-22 · US FDA — Medical DevicesClass II
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air remova - 2023-08-22 · US FDA — Medical DevicesClass II
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam - 2023-08-22 · US FDA — Medical DevicesClass II
Puritan Bennett Cuff Pressure Manager, REF: 180-03 - 2023-08-22 · US FDA — Medical DevicesClass II
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o - 2023-08-18 · US FDA — Medical DevicesClass II
Constellation Vision System, REF: 8065751150 - 2023-08-17 · US FDA — Medical DevicesClass II
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Pr - 2023-08-17 · US FDA — Medical DevicesClass II
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan - 2023-08-17 · US FDA — Medical DevicesClass II
SOZO Bilateral Arm L-Dex Software - 2023-08-16 · US FDA — Medical DevicesClass II
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrilla - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0 - 2023-08-16 · US FDA — Medical DevicesClass II
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6