Browse recalls
Alert level: Class II
- 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: - 2026-06-23 · US FDA — Medical DevicesClass II
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO ch - 2026-06-19 · US FDA — Medical DevicesClass II
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelch - 2026-06-19 · US FDA — Medical DevicesClass II
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. De - 2026-06-19 · US FDA — Medical DevicesClass II
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys - 2026-06-17 · US FDA — Medical DevicesClass II
Ventriculostomy Kit, REF: 46154 - 2026-06-16 · US FDA — Medical DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator - 2026-06-16 · US FDA — Medical DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator - 2026-06-16 · US FDA — Medical DevicesClass II
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60c - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH146 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA10 - 2026-06-12 · US FDA — Medical DevicesClass II
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum o - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREO - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Nu - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PR - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM18 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number - 2026-06-11 · US FDA — Medical DevicesClass II
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades - 2026-06-11 · US FDA — Medical DevicesClass II
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, M - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart - 2026-05-27 · US FDA — Medical DevicesClass II
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 - 2026-05-27 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack - 2026-04-30 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), - 2026-04-30 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T - 2026-04-28 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 ( - 2026-04-28 · US FDA — Medical DevicesClass II
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ - 2026-04-28 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X - 2026-04-23 · US FDA — Medical DevicesClass II
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. - 2026-04-14 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): - 2026-04-14 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. - 2026-04-13 · US FDA — Medical DevicesClass II
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577 - 2026-04-08 · US FDA — Medical DevicesClass II
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device - 2026-04-06 · US FDA — Medical DevicesClass II
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m - 2026-04-01 · US FDA — Medical DevicesClass II
i-STAT G3+ cartridge; List Number: 03P78-26; - 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 - 2026-03-26 · 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 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 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 — FoodClass II
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. - 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 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.