Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Num - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/ - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Numb - 2026-01-07 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR - 2026-01-05 · US FDA — Medical DevicesClass II
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem - 2026-01-05 · US FDA — Medical DevicesClass II
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 - 2025-12-31 · US FDA — Medical DevicesClass II
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN - 2025-12-30 · US FDA — Medical DevicesClass II
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 - 2025-12-26 · US FDA — Medical DevicesClass II
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. - 2025-12-24 · US FDA — Medical DevicesClass II
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit - 2025-12-24 · US FDA — Medical DevicesClass II
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen - 2025-12-23 · US FDA — Medical DevicesClass II
Focalyx Fusion - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2- - 2025-12-22 · US FDA — Medical DevicesClass I
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic - 2025-12-19 · US FDA — Medical DevicesClass II
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - 2025-12-19 · US FDA — Medical DevicesClass I
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520; - 2025-12-19 · US FDA — Medical DevicesClass I
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660; - 2025-12-19 · US FDA — Medical DevicesClass I
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560; - 2025-12-19 · US FDA — Medical DevicesClass II
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 - 2025-12-19 · US FDA — Medical DevicesClass II
Alphenix INFX-8000F, interventional fluoroscopic x-ray system - 2025-12-19 · US FDA — Medical DevicesClass I
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680; - 2025-12-19 · US FDA — Medical DevicesClass II
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C - 2025-12-16 · US FDA — Medical DevicesClass II
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10F; Model Number: 722002; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722027; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20; Model Number: 722028; - 2025-12-15 · US FDA — Medical DevicesClass II
Product Name: Allura Xper FD10C; Model number: 722001; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10; Model Number: 722003; - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722011; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20/20; Model Number: 722038; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722005; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20; Model Number: 722012; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20/10; Model Number: 722029; - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) - 2025-12-12 · US FDA — Medical DevicesClass II
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr - 2025-12-12 · US FDA — Medical DevicesClass II
Philips Azurion system; Software Version Number: R3.1; - 2025-12-12 · US FDA — Medical DevicesClass II
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc - 2025-12-10 · US FDA — Medical DevicesClass II
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) - 2025-12-10 · US FDA — Medical DevicesClass II
MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-0149 - 2025-12-10 · US FDA — Medical DevicesClass II
SMV DSI, System, Tomography, Computed, Emission - 2025-12-09 · US FDA — Medical DevicesClass II
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Softw - 2025-12-08 · US FDA — Medical DevicesClass II
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M - 2025-12-05 · US FDA — Medical DevicesClass II
BVI Leos Laser and Endoscopy System. Model Number: OME6000U. - 2025-12-05 · US FDA — Medical DevicesClass II
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202 - 2025-11-28 · US FDA — Medical DevicesClass II
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft - 2025-11-28 · US FDA — Medical DevicesClass II
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation - 2025-11-28 · US FDA — Medical DevicesClass II
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO - 2025-11-26 · US FDA — Medical DevicesClass II
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical DevicesClass II
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pac - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO - 2025-11-26 · US FDA — Medical DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L - 2025-11-24 · US FDA — Medical DevicesClass II
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 - 2025-11-24 · US FDA — Medical DevicesClass II
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 - 2025-11-22 · US FDA — Medical DevicesClass II
Male Fertility Sperm Test for Home Use (Cassette) - 2025-11-22 · US FDA — Medical DevicesClass II
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test - 2025-11-22 · US FDA — Medical DevicesClass II
Vivoo Protein Test - 2025-11-22 · US FDA — Medical DevicesClass II
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in - 2025-11-22 · US FDA — Medical DevicesClass II
S. Typhi/Para Typhi A Antigen - 2025-11-21 · US FDA — Medical DevicesClass II
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK - 2025-11-20 · US FDA — Medical DevicesClass II
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower - 2025-11-20 · US FDA — Medical DevicesClass II
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90 - 2025-11-17 · US FDA — Medical DevicesClass II
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116, - 2025-11-17 · US FDA — Medical DevicesClass II
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, - 2025-11-14 · US FDA — Medical DevicesClass I
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; - 2025-11-13 · US FDA — Medical DevicesClass II
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 - 2025-11-07 · US FDA — Medical DevicesClass II
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio