Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-04-01 · US FDA — Medical DevicesClass II
i-STAT EG7+ cartridge; List Number: 03P76-25; - 2026-03-31 · US FDA — Medical DevicesClass II
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap - 2026-03-30 · US FDA — Medical DevicesClass II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 - 2026-03-30 · US FDA — Medical DevicesClass II
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio - 2026-03-27 · US FDA — Medical DevicesClass I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 - 2026-03-26 · US FDA — Medical DevicesClass II
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 - 2026-03-25 · US FDA — Medical DevicesClass III
Heraeus, PALAMIX uno. Material Number: 66057893. - 2026-03-25 · US FDA — Medical DevicesClass I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 - 2026-03-25 · US FDA — Medical DevicesClass III
Heraeus, PALAMIX duo. Material Number: 66057897. - 2026-03-25 · US FDA — Medical DevicesClass II
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 - 2026-03-23 · US FDA — Medical DevicesClass II
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: - 2026-03-23 · US FDA — Medical DevicesClass II
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA - 2026-03-19 · US FDA — Medical DevicesClass I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as - 2026-03-19 · US FDA — Medical DevicesClass II
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended - 2026-03-18 · US FDA — Medical DevicesClass II
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. - 2026-03-17 · US FDA — Medical DevicesClass II
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; - 2026-03-16 · US FDA — Medical DevicesClass II
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline - 2026-03-16 · US FDA — Medical DevicesClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL - 2026-03-16 · US FDA — Medical DevicesClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE - 2026-03-16 · US FDA — Medical DevicesClass II
Access Total T4 Calibrator, Catalog No. 33805 - 2026-03-16 · US FDA — Medical DevicesClass II
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV - 2026-03-16 · US FDA — Medical DevicesClass II
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T - 2026-03-13 · US FDA — Medical DevicesClass II
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat - 2026-03-13 · US FDA — Medical DevicesClass II
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit - 2026-03-13 · US FDA — Medical DevicesClass II
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat - 2026-03-12 · US FDA — Medical DevicesClass I
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 - 2026-03-12 · US FDA — Medical DevicesClass II
iLet Bionic Pancreas, REF: BB1001 - 2026-03-12 · US FDA — Medical DevicesClass II
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor - 2026-03-12 · US FDA — Medical DevicesClass II
ARTIS Pheno VE30A and VE40A, Model 10849000 - 2026-03-11 · US FDA — Medical DevicesClass II
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f - 2026-03-11 · US FDA — Medical DevicesClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 - 2026-03-11 · US FDA — Medical DevicesClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A - 2026-03-10 · US FDA — Medical DevicesClass II
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US - 2026-03-10 · US FDA — Medical DevicesClass II
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. - 2026-03-07 · US FDA — Medical DevicesClass II
Philips Spectral CT on Rails. Model Number: 728334. - 2026-02-27 · US FDA — Medical DevicesClass II
SIGNA Premier systems - 2026-02-27 · US FDA — Medical DevicesClass II
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/ - 2026-02-23 · US FDA — Medical DevicesClass II
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;