Browse recalls
Issuing authority: US FDA — Medical Devices
- 2025-06-25 · US FDA — Medical DevicesClass II
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 - 2025-06-25 · US FDA — Medical DevicesClass II
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 - 2025-06-20 · US FDA — Medical DevicesClass II
GE Signa Artist, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-20 · US FDA — Medical DevicesClass II
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System - 2025-06-18 · US FDA — Medical DevicesClass II
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt - 2025-06-18 · US FDA — Medical DevicesClass II
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr - 2025-06-17 · US FDA — Medical DevicesClass II
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo - 2025-06-17 · US FDA — Medical DevicesClass II
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwar - 2025-06-16 · US FDA — Medical DevicesClass II
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) - 2025-06-13 · US FDA — Medical DevicesClass II
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8 - 2025-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYND - 2025-06-12 · US FDA — Medical DevicesClass II
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl - 2025-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF - 2025-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B - 2025-06-12 · US FDA — Medical DevicesClass II
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c - 2025-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564 - 2025-06-12 · US FDA — Medical DevicesClass II
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP - 2025-06-10 · US FDA — Medical DevicesClass II
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F - 2025-06-10 · US FDA — Medical DevicesClass II
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18 - 2025-06-10 · US FDA — Medical DevicesClass II
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Devic - 2025-06-10 · US FDA — Medical DevicesClass II
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO - 2025-06-10 · US FDA — Medical DevicesClass II
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num - 2025-06-10 · US FDA — Medical DevicesClass II
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu - 2025-06-06 · US FDA — Medical DevicesClass III
Akreos, SKU: AO60P0300. Akreos intraocular lenses - 2025-06-03 · US FDA — Medical DevicesClass II
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200 - 2025-06-03 · US FDA — Medical DevicesClass I
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic - 2025-05-29 · US FDA — Medical DevicesClass II
Intera 1.5T Achieva Nova-Dual Product Number: 781173; - 2025-05-29 · US FDA — Medical DevicesClass II
Intera 1.5T Explorer/Nova Dual Product Number: 781108; - 2025-05-29 · US FDA — Medical DevicesClass II
SmartPath to dStream for 1.5T; Product Number: 782146; - 2025-05-29 · US FDA — Medical DevicesClass II
Intera 1.5T Achieva IT Nova Product Number: 781175 - 2025-05-28 · US FDA — Medical DevicesClass II
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Tri - 2025-05-23 · US FDA — Medical DevicesClass II
SIGNA Architect - 2025-05-23 · US FDA — Medical DevicesClass II
SIGNA Architect AIR - 2025-05-21 · US FDA — Medical DevicesClass I
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, - 2025-05-16 · US FDA — Medical DevicesClass II
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system - 2025-05-16 · US FDA — Medical DevicesClass II
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software - 2025-05-15 · US FDA — Medical DevicesClass I
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36 - 2025-05-12 · US FDA — Medical DevicesClass II
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 - 2025-05-12 · US FDA — Medical DevicesClass II
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con - 2025-05-12 · US FDA — Medical DevicesClass II
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: - 2025-05-12 · US FDA — Medical DevicesClass II
Baxter Novum IQ Syringe Pump, product code 40800BAXUS, - 2025-05-12 · US FDA — Medical DevicesClass II
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA - 2025-05-12 · US FDA — Medical DevicesClass I
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK- - 2025-05-12 · US FDA — Medical DevicesClass I
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), - 2025-05-12 · US FDA — Medical DevicesClass II
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y - 2025-05-12 · US FDA — Medical DevicesClass II
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 - 2025-05-09 · US FDA — Medical DevicesClass II
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S - 2025-05-08 · US FDA — Medical DevicesClass II
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4 - 2025-05-06 · US FDA — Medical DevicesClass II
PhenoMATRIX - 2025-05-05 · US FDA — Medical DevicesClass II
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V - 2025-05-05 · US FDA — Medical DevicesClass II
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste - 2025-05-05 · US FDA — Medical DevicesClass II
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL - 2025-05-02 · US FDA — Medical DevicesClass II
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) - 2025-04-30 · US FDA — Medical DevicesClass II
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot - 2025-04-30 · US FDA — Medical DevicesClass II
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot - 2025-04-29 · US FDA — Medical DevicesClass II
Azure S DR MRI SureScan, Product number W3DR01 - 2025-04-28 · US FDA — Medical DevicesClass II
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog - 2025-04-25 · US FDA — Medical DevicesClass III
AcoSound. Model Number: LW12-BTE-M - 2025-04-24 · US FDA — Medical DevicesClass II
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. - 2025-04-24 · US FDA — Medical DevicesClass II
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. - 2025-04-24 · US FDA — Medical DevicesClass II
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES. - 2025-04-24 · US FDA — Medical DevicesClass II
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. - 2025-04-24 · US FDA — Medical DevicesClass II
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. - 2025-04-24 · US FDA — Medical DevicesClass II
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. - 2025-04-24 · US FDA — Medical DevicesClass II
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. - 2025-04-24 · US FDA — Medical DevicesClass II
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. - 2025-04-23 · US FDA — Medical DevicesClass III
Apo B Reagent, REF: OSR6143 - 2025-04-23 · US FDA — Medical DevicesClass II
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwar - 2025-04-15 · 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, 00-1007 - 2025-04-09 · US FDA — Medical DevicesClass II
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables t - 2025-04-08 · US FDA — Medical DevicesClass II
Artix MT Thrombectomy Device, REF: 32-102 - 2025-04-08 · US FDA — Medical DevicesClass II
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4 - 2025-04-03 · US FDA — Medical DevicesClass II
Enhanced Verify Evaluation Handset (CFN HH90130FA) - 2025-03-27 · US FDA — Medical DevicesClass II
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 1.5T Master/Nova, Model Number: 781106; - 2025-03-24 · US FDA — Medical DevicesClass II
SmartPath to dStream for 3.0T, Model Number: 782145; - 2025-03-24 · US FDA — Medical DevicesClass II
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;