223 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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iLet Bionic Pancreas, REF: BB1001
FDA Recall
Open, Classified
·Beta Bionics, Inc.·Product code QFG·March 12, 2026
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·August 28, 2025
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code OZO·July 31, 2024
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code OZP·July 31, 2024
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868 MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code OYC·July 31, 2024
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
FDA Recall
Open, Classified
·Product code QFG·March 12, 2026
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
FDA Recall
Open, Classified
·NovaSignal Corp.·Product code IYN·December 16, 2022
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.
FDA Recall
Open, Classified
·MICROVENTION INC.·Product code QCA·December 11, 2024
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
FDA Recall
Open, Classified
·Powers Medical Devices, LLC·Product code HCC·October 1, 2015
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S x inches or 6mm x 6mm) Component: N/A
FDA Recall
Open, Classified
·American Surgical Company, LLC·Product code HBA·September 18, 2024
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
FDA Recall
Open, Classified
·Abbott Laboratories·Product code CKA·June 10, 2021
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
FDA Recall
Open, Classified
·Abbott Laboratories·Product code CKA·June 10, 2021
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
FDA Recall
Open, Classified
·Abbott Laboratories·Product code CKA·June 10, 2021
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
FDA Recall
Open, Classified
·Abbott Laboratories·Product code CKA·June 10, 2021
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KKX·April 8, 2024
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Recall
Open, Classified
·MRP, LLC dba Aquabiliti·Product code NGT·December 28, 2023
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Recall
Open, Classified
·Whele LLC DBA Perch·Product code IRT·October 24, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
FDA Recall
Open, Classified
·Whele LLC DBA Perch·Product code IRT·October 24, 2022