Browse recalls
Alert level: Class II
- 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 - 2026-04-10 · US FDA — Medical DevicesClass II
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P - 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 - 2026-04-06 · US FDA — Medical DevicesClass II
INZONE DETACHMENT SYSTEM, REF: M00345100950 - 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 - 2026-03-16 · US FDA — Medical DevicesClass II
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 - 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 mater - 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. - 2026-03-09 · US FDA — Medical DevicesClass II
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS i - 2026-03-09 · US FDA — Medical DevicesClass II
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system - 2026-03-07 · US FDA — Medical DevicesClass II
Philips Spectral CT on Rails. Model Number: 728334. - 2026-02-27 · US FDA — FoodClass II
SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VIN - 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; - 2026-02-20 · US FDA — Medical DevicesClass II
Radius VSM ECG pre-connected Set, REF: 4842, 4695 - 2026-02-20 · US FDA — Medical DevicesClass II
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 - 2026-02-16 · US FDA — Medical DevicesClass II
THORACIC ROBOTS, DYNJ908777B - 2026-02-16 · US FDA — Medical DevicesClass II
Airway Exam Kit, DYKE1796 - 2026-02-16 · US FDA — Medical DevicesClass II
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K - 2026-02-16 · US FDA — Medical DevicesClass II
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9 - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 620G Insulin Pump (MMT-1750) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm Insulin Pump (MMT-712, MMT-715) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) - 2026-02-13 · US FDA — Medical DevicesClass II
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) - 2026-02-13 · US FDA — Medical DevicesClass II
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH - 2026-02-13 · US FDA — Medical DevicesClass II
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 530G Insulin Pump (MMT-551, MMT-751) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) - 2026-02-13 · US FDA — Medical DevicesClass II
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) - 2026-02-09 · US FDA — Medical DevicesClass II
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 - 2026-02-06 · US FDA — Medical DevicesClass II
BD Kiestra" ReadA; Catalog No.: 446948. - 2026-01-30 · US FDA — Medical DevicesClass II
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 - 2026-01-30 · US FDA — Medical DevicesClass II
DxC 700 AU, REF: B86444, B86446 - 2026-01-30 · US FDA — Medical DevicesClass II
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including - 2026-01-30 · US FDA — Medical DevicesClass II
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 - 2026-01-30 · US FDA — Medical DevicesClass II
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize - 2026-01-30 · US FDA — Medical DevicesClass II
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software V - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Softwa - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 So - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Ve - 2026-01-29 · US FDA — Medical DevicesClass II
Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software - 2026-01-21 · US FDA — Medical DevicesClass II
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000 - 2026-01-21 · US FDA — Medical DevicesClass II
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK, Part No. 00055360004. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055415005. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Model No. 00055430010. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055430008. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000; Part No. 00055415008. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK; Part No. 00055407511. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK; Part No. 00055360011. - 2026-01-20 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK; Part No. 00055407508.